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Validation Scientist

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Main Duties and Responsibilities:
Working as part of the Validation team on process, software, cleaning and equipment validation activities.
Generation and execution of required Validation protocols and SOPs in accordance with internal procedures and industry guidelines.
Review and approval of Validation protocols and reports.
Equipment troubleshooting and follow-up in house and with external vendors.
Ensure consistency on Validation/Qualification approach across systems and projects.
Communicate and liaise with other departments on Validation/Qualification issues.
Documentation of all activities to required standards including CAPA and Change Controls.
Conducting Validation trials and studies.
Perform risk analysis on new equipment/software using FMEA techniques.
Involvement in participation and preparation for third party audits – FDA, IMB, ISO 13485.
Principal Qualification Required:
Science or engineering degree.
Experience:
Ideally a minimum of 2 years experience of validating equipment and/or processes in a regulated Healthcare environment.
Strong understanding of validation concepts and lifecycle documentation.
Knowledge of GMP (Good Manufacturing Practice).
Skills:
Excellent Leadership skills, ability to motivate team members within the organisation.
Good organisational, communication and interpersonal skills.
Good problem solving and decision making skills.
Attention to detail.
Self-motivation.
Ability to work as part of a team.
If you would like further Information you can contact the recruiter directly:

Theresa Heffernan | Tel: +353 (0) 1 507 9252


PLEASE APPLY DIRECTLY BY CLICKING HERE


Head of Institute and Full Professorship (W3) of Immunobiology

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Area of research:

Scientific / postdoctoral posts


Job description:

Job Description: Special consideration is given to scientists who have a strong basic research program and excellent track record in the field of molecular and genetic mechanisms that guide ontogenesis, differentiation and function of immune cells and their response to environmental challenge. Research on response to biotic stress and the balance between pathogen defense and tolerance to self is particularly welcome. The successful candidate is expected to participate in teaching Genetics at the Faculty of Biology.
Your Qualifications: Prerequisites for this position are a university and a doctoral degree, teaching skills at university level, excellent academic achievements and a productive and promising research program. The future holder of this position will be appointed to LMU as a university professor (pay grade W3) under the terms of a private-law contract and will be granted leave of absence in order to lead the Institute at Helmholtz Zentrum München based on an employment agreement under private law.
Our Offer: The Helmholtz Zentrum München and LMU are equal opportunity employers and aim to increase the number of female faculty members. Therefore, applications from female candidates are explicitly encouraged. Both institutions support dual career couples. Disabled candidates with essentially equal qualifications will be given preference. Information concerning the scientific scope of the position can be obtained from Prof. Wolfgang Hammerschmidt, Helmholtz Zentrum München (hammerschmidt@helmholtz-muenchen.de, phone +49/89/3187-1506) or Prof. Michael Boshart, Ludwig-Maximilians-Universität München (boshart@lmu.de, phone +49 89 2180-74600). Applications including curriculum vitae, list of publications, a brief summary of present and future research interests, proof of teaching experience and copies of relevant documents should be sent as hard copy before February 1, 2013 to Prof. Dr. Günther Wess, CEO and President, Helmholtz Zentrum München, Ingolstädter Landstraße 1, D-85764 Neuherberg. In addition, the form available at www.biologie.uni-muenchen.de/fakultaet/organisation/dekanat/index.html needs to be completed and send together with the application as a PDF to the E-Mail-address: dekanat19@lmu.de.


Contact:

We look forward to receiving your application via Mail or e-mail: Günther Wess, Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH) Management Department Ingolstädter Landstraße 1 85764 Neuherberg Germany phone e-mail: dekanat19@lmu.de


Clinical Project Manager - NL / Belgium

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Clinical Project Manager - Mid Sized CRO (Netherlands/Belgium)

JOB SUMMARY

My client is a global midsized CRO based in the Netherlands, and looking for a Clinical Project Manager to join their office based team.

My client is very reputable within the market and provides competitive salaries as well as outstanding career development opportunities. Clinical Project Manager – Mid Sized CRO (Netherlands/Belgium)

JOB SUMMARY

My client is a global midsized CRO based in the Netherlands, and looking for a Clinical Project Manager to join their office based team. My client is very reputable within the market and provides competitive salaries as well as outstanding career development opportunities. You will be responsible for managing a series of global cardiovascular studies. You can be part office / part home based for this role.

JOB TITLE

Clinical Project Manager / Project Manager / Senior Project Manager / Clinical Project Leader / Study Manager

LOCATION

Netherlands/Belgium

BENEFITS

Competitive Salary
Car Allowance & Bonus
Flexible working hours
Private Health Care
Life Insurance
Ongoing Training and Career Development Opportunities


ROLE/DESCRIPTION


You will be responsible for overall project management of a study. To lead the cross functional project teams including clinical monitoring, data management, medical services and third-party vendors, to ensure quality, on-time and within budget deliverables for Phase II-IV clinical trials. You will have contact with the sponsor to ensure the timelines are being met, and you will have responsibility for managing the budgets, as well as reporting and tracking.







REQUIREMENTS
•A Life Science or Nursing Degree
•Extensive experience in clinical research is a MUST and the successful candidate will have a full service Project Management background.
•Ideally you will have experience working in Cardiovascular studies


ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com


TO APPLY

If you would like to discuss this vacancy further, please call Principal Consultant Natalie Hall on +44 (0)20 3189 0463, or email nhall@i-pharmconsulting.com. If this role is not suitable, Natalie is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


KEY WORDS:

Clinical Project Manager / Project Manager / CPM / PM / Clinical Project Leader / Clinical Research Associate / CRA / Clinical Research / Clinical Research Scientist / Project Manager / Clinical Project Director / Director of Clinical Operations / Clinical Study Manager / Pharma / CRO / Senior CPM / Lead CPM / Project Director /Senior Clinical Project Manager / Belgium / Netherlands / Cardiovascular

Clinical Project Director, Global CRO - HOME BASED

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Clinical Project Director, Global CRO

BACKGROUND

Clinical Project Director / Director / Senior Clinical Project Manager required by leading International CRO. The Clinical Project Director /Senior Clinical Project Manager will be working from a strategic perspective with this established international company who are growing their European Project Management/ Project Manager Function. Clinical Project Director, Global CRO

BACKGROUND

Clinical Project Director / Director / Senior Clinical Project Manager required by leading International CRO. The Clinical Project Director /Senior Clinical Project Manager will be working from a strategic perspective with this established international company who are growing their European Project Management/ Project Manager Function. Role can be based from the client offices in the M4 corridor region (London, Berkshire) or can be home-based anywhere in the UK. Therapy areas include: Oncology, Cardiovascular, Infectious Disease, Respiratory and CNS.


JOB TITLE
Clinical Project Director / Director / Senior Clinical Project Manager

ROLE

As a Clinical Project Director you will be leading large scale international projects from a Project Management, Line Management and Strategic perspective.

This is a full life cycle Project Management role. The successful candidate will have full responsibility for finance/budgets and timescales on a range in international clinical trials across a range of therapy areas. Company details and a full job spec is available upon application – please call or email Natalie.

BENEFITS

Generous basic salary
Car or Car Allowance
Bonus
Pension
Private Healthcare
Life Assurance


EXPERIENCE REQUIRED

To apply:

Minimum of 5 years Clinical Project Management
Line management of Project Manager
Cross functional Project Management experience
International experience
CRO experience

TO APPLY

If you would like to discuss this vacancy further, please call Principal Consultant Natalie Hall on +44 (0)20 3189 0463, or email nhall@i-pharmconsulting.com. If this role is not suitable, Natalie is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist recruitment company focused on mid to high-level roles in Clinical Research, Regulatory & Medical Affairs. We recruit for both permanent and contract staff across the UK & Europe. Our clients include Pharmaceutical, Biotechnology, Contract Research and Medical Device companies.











KEY WORDS

Project Director, Director, Senior Clinical Project Manager, Project Manager, Oncology, Cardiovascular, Infectious Disease, Respiratory, CNS, London, UK, Berkshire, Buckinghamshire, SE, South East, Maidenhead, Reading, Marlow, Oxford, Project Director, Director, Senior Clinical Project Manager, Project Manager, Oncology, Cardiovascular, Infectious Disease, Respiratory, CNS, London, UK, Berkshire, Buckinghamshire, SE, South East, Maidenhead, Reading, Marlow, Oxford, Project Director, Director, Senior Clinical Project Manager, Project Manager, Oncology, Cardiovascular, Infectious Disease, Respiratory, CNS, London, UK, Berkshire, Buckinghamshire, SE, South East, Maidenhead, Reading, Marlow, Oxford,

Clinical Operations Manager

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Clinical Operation Manager, 7 month Contract, Cambridge

Introduction

Our client is a leading Fortune 500, Biotechnology Company. With headquarters in the USA, my client employs over 500 staff in their UK offices, located in Cambridge and Middlesex on both a permanent and contract basis.
Clinical Operation Manager, 7 month Contract, Cambridge

Introduction

Our client is a leading Fortune 500, Biotechnology Company. With headquarters in the USA, my client employs over 500 staff in their UK offices, located in Cambridge and Middlesex on both a permanent and contract basis.

A market leader, our client strives to develop products that change people's lives and in the last 30 years have transformed the management of anaemia, inflammation, and cancer. They have a thriving pipeline and are currently very active in recruiting candidates to join the team on a contract basis.

Both UK sites are easily reachable by mainline BR and have excellent road links with ample free car parking.

Our client knows they offer a great place to work. Our client understands that each candidate is not the same, and no two roles are either. That's why they permit up to two days working from home per week depending on the role. Moreover, it's a place where you will be more than a contractor- you will be one of the team, and that even means an early Friday finish!


Job Summary

In this challenging role you will be responsible for local protocol and site feasibility assessment.
Locally plans, executes, and manages and reports on our clients sponsored studies
Single point of contact at a project level for Global Study Management.

This includes:-

Manages the feasibility process and ensure adequate site selection
Plans, manages and executes all Our clients sponsored study related activities within the affiliate
Ensures the timeliness and quality of study deliverables in accordance with SOPs, ICH/GCP guidelines and local regulations
Coordinates tasks when those are allocated to support COM-managed studies
Actively contributes to results oriented department goals
Drives continuous improvement of Global Clinical Study Management (GCSM)
Promotes operational and scientific excellence within local GCSM
Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
Provides a single point of contact at the study level for Local affiliate staff and at country level for GSM


Essential Skills & Qualification

BA/BS/BSc or qualified nurse (RN)
Work experience working in life sciences or medically related field, biopharmaceutical experience ( including clinical research clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
Additionally a broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Clinical trial management experience
Operational performance measurement experience
International collaboration experience

Supplementary Requirements:

Software Competence: MS Office, MS Project,
Valid Driving License: Not required
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: No

Employment Information:

Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 7 Months
Location: UK; Location Office Based access near e.g. M11
Plan Start Date: 7th January 2012, Please do not apply if you are unable to meet this start date.
Contract Benefits: Day Rate inclusive of benefits

Keywords: Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, GCP, Manager, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Feasibility , Essential Documents, SOPs, Investigator Meeting, REC,

Assigned Consultant: Avril Horn at CSL Recruitment on 01932 234686
Please feel free to call for a detailed Job Description or additional information

Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be re-marketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.

North Carolina Family Practice Physician

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Our Eastern North Carolina Multi-specialty Group client is seeking a BE/BC Family Medicine physician to join a Group of 27 providers in Family Medicine, Pediatrics, Internal Medicine, Surgery, Med/Peds, and various Sub-Specialties. ... Our Eastern North Carolina Multi-specialty Group client is seeking a BE/BC Family Medicine physician to join a Group of 27 providers in Family Medicine, Pediatrics, Internal Medicine, Surgery, Med/Peds, and various Sub-Specialties.

Highlights include:
:Qualifies for government student loan repayment options
:Schedule is M - F, 8AM - 5PM
:Telephone call on a rotating basis with other primary care physicians
:Average patient load is 25 per day
:Practice officers full range of healthcare services to patients of all ages

Benefits include:
:Annual Stipend
:Relocation Assistance
:Incentive/Productivity Plan
:Vacation
:Malpractice (with tail)
:401K
:457b
:Insurance
:Disability
:Life

Our Medical Group client employs over 325 providers including primary care and specialists. The group offers the infrastructure needed to manage a modern medical practice including processes for billing and collection, group contracting, electronic medical records and other technologies.

The Hospital is a 117-bed acute care, not-for-profit hospital located in Eastern North Carolina working every day to improve the health of the county's people. The Group gives patients access to state-of-the-art services provided by an academic medical center. Being a part of the Group gives patients access to state-of-the-art services provided by an academic medical center.


Where History and Beauty Meet Nestled in eastern North Carolina, the city is a lively, growing community that maintains the relaxed ambiance that is a hallmark of Southern living. From its scenic historic district to unique town common, the local area offers residents a taste of Southern charm and hospitality. However, residents also enjoy a wide array of recreational opportunities including golf, water sports, and the arts. The city is a "front porch kind of town" that maintains the relaxed ambience of the Old South. Located just 30 minutes from Greenville, one hour from Raleigh/RTP and two hours from the North Carolina beaches, residents of this area have easy access to a wide variety of activities.

Family Practice Physician Four Corners Region

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Our government client is actively seeking full spectrum Adult Medicine Physicians (Family Practice or Internal Medicine) for an exceptional opportunity in the Four Corners region of Northern Arizona.

We run hospitals and clinics for Native Americans who live on and near the largest Indian reservation in the United States. The territory we cover is larger than West Virginia, predominantly within Arizona and New Mexico. ... Our government client is actively seeking full spectrum Adult Medicine Physicians (Family Practice or Internal Medicine) for an exceptional opportunity in the Four Corners region of Northern Arizona.

We run hospitals and clinics for Native Americans who live on and near the largest Indian reservation in the United States. The territory we cover is larger than West Virginia, predominantly within Arizona and New Mexico. The people we serve are primarily Navajo, but a lot of Hopi, Zuni, Ute and other Tribal members are seen by our physicians every day. Inclusive health care is provided through in- patient, out- patient and community health programs centered around six hospitals, seven ambulatory health centers, and sixteen health stations.
Our people offer a rich cultural heritage and our health professionals enjoy the intangible satisfaction of doing something meaningful, maintaining the highest quality of professional services with colleagues they truly respect, while having an adventure. As a clinician, you will have the opportunity to care for patients from a culturally intriguing population and you'll be part of a dedicated, motivated and highly competent health care team that serves a vital mission.
Our 278 physicians, board eligible or (mostly) board certified in most specialties, provide care to 210,000 Native American people. Our total staff exceeds 3,500. Our medical departments are quite diverse. We are proud of our excellent facilities and staff. Over ninety percent of our physicians were in the top 20 percent of their training programs.
Excellent backup is available at all locations. Consultation is available from colleagues at the work site, at our other medical centers, and from specialists located in nearby Albuquerque, Phoenix, Tucson and Denver. We are seeking only physicians who are U.S. Citizens, fully licensed, (You can be licensed in any state - not just Arizona or New Mexico) who have no canceled or restricted licenses anywhere. We want people who are board eligible or board certified. U.S. Citizenship is required for most specialties.
You will have a good time here! Recreational opportunities abound. We're close to skiing and mountains and lakes. There is plenty of room for hunters and fishermen. You can plant a garden, or begin a hike right off your front porch. You can get involved in exhilarating desert running, hot air ballooning, gliders or hang gliding, white water river rafting, or relax and absorb the incredible sunsets, or finally make it through all those books you've been hoping to read. Or write the great novel you've had gnawing inside you. This is a great place to start or raise a family or to have family, friends and relatives visit.
We offer the atmosphere and opportunities for an enjoyable and challenging medical practice, unlimited personal growth and exhilarating recreation.
Basic qualifications to be considered for any of the medical health care positions are you must be a U.S. Citizen, have a non-restricted license and have completed a residency in the specialty you are requesting and thus be board eligible
Some Perks:
1. You gain experience in ALL aspects of practice
2. Malpractice is covered under the Federal Tort Claims Act
3. Each facility we work with qualifies for Loan Repayment program.
4. Some sites also qualify for the National Health Service Corp Loan Repayment of up to $170,000..

Adult Medicine Physician for Northern Arizona

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Our government client is actively seeking full spectrum Adult Medicine Physicians (Family Practice or Internal Medicine) for an exceptional opportunity in the Four Corners region of Northern Arizona.

We run hospitals and clinics for Native Americans who live on and near the largest Indian reservation in the United States. The territory we cover is larger than West Virginia, predominantly within Arizona and New Mexico. ... Our government client is actively seeking full spectrum Adult Medicine Physicians (Family Practice or Internal Medicine) for an exceptional opportunity in the Four Corners region of Northern Arizona.

We run hospitals and clinics for Native Americans who live on and near the largest Indian reservation in the United States. The territory we cover is larger than West Virginia, predominantly within Arizona and New Mexico. The people we serve are primarily Navajo, but a lot of Hopi, Zuni, Ute and other Tribal members are seen by our physicians every day. Inclusive health care is provided through in- patient, out- patient and community health programs centered around six hospitals, seven ambulatory health centers, and sixteen health stations.
Our people offer a rich cultural heritage and our health professionals enjoy the intangible satisfaction of doing something meaningful, maintaining the highest quality of professional services with colleagues they truly respect, while having an adventure. As a clinician, you will have the opportunity to care for patients from a culturally intriguing population and you'll be part of a dedicated, motivated and highly competent health care team that serves a vital mission.
Our 278 physicians, board eligible or (mostly) board certified in most specialties, provide care to 210,000 Native American people. Our total staff exceeds 3,500. Our medical departments are quite diverse. We are proud of our excellent facilities and staff. Over ninety percent of our physicians were in the top 20 percent of their training programs.
Excellent backup is available at all locations. Consultation is available from colleagues at the work site, at our other medical centers, and from specialists located in nearby Albuquerque, Phoenix, Tucson and Denver. We are seeking only physicians who are U.S. Citizens, fully licensed, (You can be licensed in any state - not just Arizona or New Mexico) who have no canceled or restricted licenses anywhere. We want people who are board eligible or board certified. U.S. Citizenship is required for most specialties.
You will have a good time here! Recreational opportunities abound. We're close to skiing and mountains and lakes. There is plenty of room for hunters and fishermen. You can plant a garden, or begin a hike right off your front porch. You can get involved in exhilarating desert running, hot air ballooning, gliders or hang gliding, white water river rafting, or relax and absorb the incredible sunsets, or finally make it through all those books you've been hoping to read. Or write the great novel you've had gnawing inside you. This is a great place to start or raise a family or to have family, friends and relatives visit.
We offer the atmosphere and opportunities for an enjoyable and challenging medical practice, unlimited personal growth and exhilarating recreation.
Basic qualifications to be considered for any of the medical health care positions are you must be a U.S. Citizen, have a non-restricted license and have completed a residency in the specialty you are requesting and thus be board eligible
Some Perks:
1. You gain experience in ALL aspects of practice
2. Malpractice is covered under the Federal Tort Claims Act
3. Each facility we work with qualifies for Loan Repayment program.
4. Some sites also qualify for the National Health Service Corp Loan Repayment of up to $170,000..

Primary Care Physician needed!

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Coverage Dates Requested: M-F (8a - 5p)
Specific Job Details:

BC required in any PC specailty
OCC - med experence prefered but not required
Travelers Welcome

18-30 patients per day
Pay 75 - 85 per hour

Locum to perm option available

Full office staff
Wil need to get admitting privilages with the hospital

Reason for need : current physician leaving + additional help needed at another site.

- Clinical Trial Liaison (CTL) – France

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- Clinical Trial Liaison (CTL) – France Homebased –Excellent Package Clinical Trial Liaison staff (CTL) needed to be Home based in France. The specific function of a CTL is to provide scientific, medical and educational support to healthcare professionals (principle investigators and their study teams) at clinical sites. Needed is an advanced knowledge of Oncology, Clinical Research and clinical trial methodology.

Responsibilities:
• Develop the sponsors company’s reputation in Oncology.
• Develop strong relationships and communication links with PI’s, study physicians and their teams. Act as a field-based reference point for scientific and clinical expertise for study sites and clinical field operations.
• Support sponsored trials in the future and that are on-going.
• Respond to request for investigator-sponsored research in line with company policies and procedures.
Experience:
• Strong Oncology experience in the Pharmaceutical industry – (mandatory)
• Clinical trials experience.
• Understanding of clinical trial methodology and management.
• Experience working with Oncology KOLs, researchers and HCPs at all levels –
• Experience of working within the relevant National Pharmaceutical Code.
Education:
• Physician, Pharmacist, PhD in a relevant scientific field or associated qualification.
• Fluent written and spoken English, and French.
Knowledge:
• Understands the overall audit process including design, conduct and reporting.
• In-depth knowledge of the applicable GXP regulations, Good Clinical Practice,
• ICH Guidelines and National Code of Practice.
Additional Requirements:
• Able to drive or fly to attend meetings, site audits and training courses.
• Willingness to travel internationally and be away from home.
A competitive salary and benefits, gain more management experience, fantastic career progression, send your C.V. to cswain@barringtonjames.com or call Christopher Swain 0441293776644
 

Clinical trial Liaison (CTL) – Norway

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Clinical trial Liaison (CTL) – Norway Homebased –Excellent Package Clinical Trial Liaison staff (CTL) needed to be Home based in Norway. The specific function of a CTL is to provide scientific, medical and educational support to healthcare professionals (principle investigators and their study teams) at clinical sites. Needed is an advanced knowledge of Oncology, Clinical Research and clinical trial methodology.

Responsibilities:
• Develop the sponsors company’s reputation in Oncology.
• Develop strong relationships and communication links with PI’s, study physicians and their teams. Act as a field-based reference point for scientific and clinical expertise for study sites and clinical field operations.
• Support sponsored trials in the future and that are on-going.
• Respond to request for investigator-sponsored research in line with company policies and procedures.
Experience:
• Strong Oncology experience in the Pharmaceutical industry – (mandatory)
• Clinical trials experience.
• Understanding of clinical trial methodology and management.
• Experience working with Oncology KOLs, researchers and HCPs at all levels –
• Experience of working within the relevant National Pharmaceutical Code.
Education:
• Physician, Pharmacist, PhD in a relevant scientific field or associated qualification.
• Fluent written and spoken English, and Norwegian.
Knowledge:
• Understands the overall audit process including design, conduct and reporting.
• In-depth knowledge of the applicable GXP regulations, Good Clinical Practice,
• ICH Guidelines and National Code of Practice.
Additional Requirements:
• Able to drive or fly to attend meetings, site audits and training courses.
• Willingness to travel internationally and be away from home.
A competitive salary and benefits, gain more management experience, fantastic career progression, send your C.V. to cswain@barringtonjames.com or call Christopher Swain 0441293776644
 

- Clinical Trial Liaison (CTL) – Poland

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- Clinical Trial Liaison (CTL) – Poland Homebased –Excellent Package Clinical Trial Liaison staff (CTL) needed to be Home based in Poland. The specific function of a CTL is to provide scientific, medical and educational support to healthcare professionals (principle investigators and their study teams) at clinical sites. Needed is an advanced knowledge of Oncology, Clinical Research and clinical trial methodology.

Responsibilities:
• Develop the sponsors company’s reputation in Oncology.
• Develop strong relationships and communication links with PI’s, study physicians and their teams. Act as a field-based reference point for scientific and clinical expertise for study sites and clinical field operations.
• Support sponsored trials in the future and that are on-going.
• Respond to request for investigator-sponsored research in line with company policies and procedures.
Experience:
• Strong Oncology experience in the Pharmaceutical industry – (mandatory)
• Clinical trials experience.
• Understanding of clinical trial methodology and management.
• Experience working with Oncology KOLs, researchers and HCPs at all levels –
• Experience of working within the relevant National Pharmaceutical Code.
Education:
• Physician, Pharmacist, PhD in a relevant scientific field or associated qualification.
• Fluent written and spoken English, and Polish.
Knowledge:
• Understands the overall audit process including design, conduct and reporting.
• In-depth knowledge of the applicable GXP regulations, Good Clinical Practice,
• ICH Guidelines and National Code of Practice.
Additional Requirements:
• Able to drive or fly to attend meetings, site audits and training courses.
• Willingness to travel internationally and be away from home.
A competitive salary and benefits, gain more management experience, fantastic career progression, send your C.V. to cswain@barringtonjames.com or call Christopher Swain 0441293776644
 

- Clinical Trial Liaison (CTL) – Denmark

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- Clinical Trial Liaison (CTL) –Denmark Homebased –Excellent Package Clinical Trial Liaison staff (CTL) needed to be Home based in Poland. The specific function of a CTL is to provide scientific, medical and educational support to healthcare professionals (principle investigators and their study teams) at clinical sites. Needed is an advanced knowledge of Oncology, Clinical Research and clinical trial methodology.

Responsibilities:
• Develop the sponsors company’s reputation in Oncology.
• Develop strong relationships and communication links with PI’s, study physicians and their teams. Act as a field-based reference point for scientific and clinical expertise for study sites and clinical field operations.
• Support sponsored trials in the future and that are on-going.
• Respond to request for investigator-sponsored research in line with company policies and procedures.
Experience:
• Strong Oncology experience in the Pharmaceutical industry – (mandatory)
• Clinical trials experience.
• Understanding of clinical trial methodology and management.
• Experience working with Oncology KOLs, researchers and HCPs at all levels –
• Experience of working within the relevant National Pharmaceutical Code.
Education:
• Physician, Pharmacist, PhD in a relevant scientific field or associated qualification.
• Fluent written and spoken English, and Polish.
Knowledge:
• Understands the overall audit process including design, conduct and reporting.
• In-depth knowledge of the applicable GXP regulations, Good Clinical Practice,
• ICH Guidelines and National Code of Practice.
Additional Requirements:
• Able to drive or fly to attend meetings, site audits and training courses.
• Willingness to travel internationally and be away from home.
A competitive salary and benefits, gain more management experience, fantastic career progression, send your C.V. to cswain@barringtonjames.com or call Christopher Swain 0441293776644
 

Medical Manager - OTC - Top Global Company

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Medical Manager - OTC - Top Global Company

My client, a leading pharma company with offices around the world, is hiring a Medical Manager to proactively support promotional activities and provide medical support. Managing a global team, you will gain vast exposure and responsibility. Working for a well-funded growing company, the career development opportunities are endless and you will never be stagnant in your career. Reference: SB/63155/2

Medical Manager - OTC - Top Global Company

My client, a leading pharma company with offices around the world, is hiring a Medical Manager to proactively support promotional activities and provide medical support. Managing a global team, you will gain vast exposure and responsibility. Working for a well-funded growing company, the career development opportunities are endless and you will never be stagnant in your career. In a real meritocracy, you will be truly rewarded for your efforts with a £60,000 basic salary and 10% bonus.

In this position you will be a medical guru for the specific therapeutic areas and provide medical support or strategic advice to project teams. You will liaise with external KOLs and develop new business revenue. You will be proactively supporting promotional activities and the development of new products. You will be presenting at regulatory agencies globally. Managing a team of 10, my client will put a lot of trust in you.

A good candidate will be a medical doctor, pharmacist or have a life science degree with medical information or medical affairs experience within an OTC environment.

If you are looking to grow your career in a company who really values your efforts, then we want to hear from you today.

To apply, or for more information about our other opportunities, please do not hesitate to contact me, Siobhan Bailey of Nonstop Recruitment, on +44 207 940 2105 or email s.bailey@nonstop-recruitment.com.

Urgent Production/QC Technician

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QC
Technician
Radiopharmaceuticals
Excellent salary Job Ref

MS/63142/2

Job Role

Urgent Production/QC Technician



JOB DESCRIPTION

Working in Radiopharmaceuticals is an area of nuclear medicine that is working to help diagnose and treat diseases. This is an exciting area that can help to trace or treat tumours using Radioisotopes. If you are looking for the next challenge in your career, apply today.

REQUIREMENTS

UK or European pharmaceutical industry experience essential

Working as a QC analyst

Background in Chemistry

Degree in Chemistry or similar subject

Background in radiopharmaceuticals



To apply for this role please contact Matt Spiller on 02079402105 or email m.spiller@nonstop-recruitment.com

*SAS Programmer - New branch in Central Europe. Exciting role!*

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Currently available, permanent role for a Statistician with 2 years of experience in an interesting EU location (call me to find out!). DEVELOP NEW SKILSS IN A CROSS-FUNCTIONAL ENVIRONMENT!
Working in a small team responsible for data analytics in clinical research, you will receive a great opportunity to acquire cross-functional skills and will benefit greatly from close mentoring. You will work on statistical design and analysis as well as SAS programming in clinical trials covering Europe.

ACQUIRE GREAT INTERNATIONAL EXPERIENCE
By living and working abroad in a beautiful part of Central Europe you will enjoy a comfortable lifestyle, low taxation and easy travel to multiple destinations. You will also gain strong multicultural skills by joining a vibrant expat community.

REQUIRED
Life science degree and around 2 years of experience with SAS programming in public health or the pharmaceutical industry. Some experience with Biostatistical analysis. Fluent English.

CONTACT
Ivelina Georgieva from NonStop Pharma Recruitment via 0044 (0) 207 940 2105 or I.Georgieva@Nonstop-Recruitment.com

**CRAII Denmark**

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**CRAII Denmark** I am currently working with my Client to source some highly talented Clinical Research Associate/CRAII for a great opportunity in Denmark.

**CRAII Denmark**
I am currently working with my Client to source some highly talented Clinical Research Associate/CRAII for a great opportunity in Denmark.
The role offers flexibility to be either office based in Copenhagen or based from home and requires dedicated and passionate individuals to join this rapidly expanding company.
Job Duties:
• Conduct pre-study, initiation, monitoring and close out visits for research sites
• Perform source document verification and case report form review
• Perform regulatory document review
• Conduct study drug inventory
• Perform adverse event and serious adverse event reporting and follow up
• Assess patient recruitment and retention
Qualifications:
• Bachelor’s degree in Life Sciences or health related field
• Broad knowledge of medical terminology and clinical patient management
• Basic knowledge of drug therapy techniques and clinical research methodologies
• A minimum of 2 years independent monitoring experience
As a CRA you will be required to travel 60%-80% so a full driving license and car is also essential

If you feel this role would be a suitable fit for you then please get in touch with Emma Watts at Barrington James
ewatts@barringtonjames.com / 0044 (0)1293 776644
 

Clinical Study Specialist - Pharma - 12 month contract

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Clinical Study Specialist, Bucks, Pharma, Office-Based - 12 month Contract

My client is well respected Pharmaceutical Company and are looking to recruit a Clinical Study specialist for a 12 month contract. This is an excellent opportunity for a CRA with Start Up experience or a very experienced CTA, looking for career progression. The role is a freelance, 12 month contract with generous day-rate dependant on experience.

Clinical Study Specialist, Bucks, Pharma, Office-Based - 12 month Contract

My client is well respected Pharmaceutical Company and are looking to recruit a Clinical Study specialist for a 12 month contract. This is an excellent opportunity for a CRA with Start Up experience, looking for career progression. The role is a freelance, 12 month contract with generous day-rate dependant on experience.

THE ROLE

The successful applicant will be involved in executing all essential clinical trial documents and clinical trial agreements (CTAs). You will be responsible for adhering to all relevant regulations including ICH and PhRMA guidelines and the companies SOPs and policies. Your role will involve the preparation, collation and review of regulatory documents submission packages, distribution of draft essential docs to selected sites. You will be responsible for developing informed consent templates, to county specific requirements.


SKILLS REQUIRED
•You will require excellent computer skills as well as organisational skills and the ability to prioritise urgent tasks

•The successful candidate will have a strong understanding of clinical studies.

•Bachelor's degree, preferably in a science or health-related discipline

•A basic understanding of contracts and negotiations is preferred.

•Clinical research and Regulatory experience preferred.



ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com


TO APPLY

If you would like to discuss this vacancy further, please call Consultant Will Hitchcock on +44 (0)20 3189 0467, or email whitchcock@i-pharmconsulting.com. If this role is not suitable, Will is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


KEY WORDS
CRA / Clinical Research Associate / Start Up / Study Start Up / Clinical Documents / CTAs / Clinical Trial Agreements / ICF / Regulatory / CRA I / Clinical Research Associate I / CTA / Clinical Trial Administration / Clinical Research / Pharma / UK / London / Surrey / Berkshire / Buckinghamshire


Process Engineer

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For a confidential consultation call Andrew Harrison on +44 (0) 207 255 6665 or email your CV to andrew.harrison@secpharma.com

My client, a leading technical and professional service provider, is looking for an experienced Process Engineer to join a project team involved in the commissioning and qualification of upstream suprerskids before transfer to onsite qualification. Process Engineer
Based in Belgium
Contract
€ / hour Depending on Experience

For a confidential consultation call Andrew Harrison on +44 (0) 207 255 6665 or email your CV to andrew.harrison@secpharma.com

Job Summary:

My client, a leading technical and professional service provider, is looking for an experienced Process Engineer to join a project team involved in the commissioning and qualification of upstream superskids before transfer to on-site qualification.

Accountabilities/Responsibilities:

Follow up manufacturing in vendor site, using experience in CIP/SIP processes and provide solutions where necessary to reach vendor requirements
Testing CIP/SIP processes and provide solutions where necessary to reach client requirements
Coordinate meetings and discussions, in agreement with user, QA, validation and engineering departments
Provide weekly progress reports according to KPIs and action plan

Required Experience:

Qualified in Process, Biotechnology or Mechanical Engineering discipline
Minimum of 5 years’ experience in the biotechnology industry
Hands on SIP/CIP systems in the pharmaceutical industry
Broad knowledge of qualification and validation techniques in cGMP environments
Capable of working as part of a multi-discipline project team as well as an individually
Strong organisational skills and good time management
High reactivity when facing challenges such as changes in schedule
Extremely rigorous in following documentation and the project stages in accordance to clients requirements
Flexible for travel in Europe

Applicant MUST be eligible to work in the Belgium

For further details or a confidential conversation please contact me directly:

Andrew Harrison
Pharmaceutical Consultant
Manufacturing – Production/Engineering
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
andrew.harrison@secpharma.com
http://uk.linkedin.com/in/andrewjharrison

Key skills:

process engineer, process management, process engineering, qualification, qualification. pharmaceutical, qualification engineer, validation, validation engineer, cgmp, cgmp validation, gmp, cip, sip, rip, upstream, upstream production, quality assurance, engineer, engineering, engineering jobs, pharmaceutical, pharma, pharma jobs, biotech, biotechnology

Key Quality Manager

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Mein Kunde sucht aktuell einen Key Quality Manager für seinen Standort in der Schweiz nahe Luzern.
Mein Kunde ist ein weltweit führender Hersteller hochwertiger Spezialprodukte aus Glas und Kunststoff für die internationale Pharma- und Healthcare-Industrie. In den 47 Standorten in Europa, Nord- und Südamerika und Asien arbeiten über 10.000 Mitarbeiter.

Mein Kunde sucht aktuell einen Key Quality Manager für seinen Standort in der Schweiz nahe Luzern.

Das Unternehmen bietet Ihnen einen interessanten, dynamischen und vor allem internationalen Arbeitsplatz, mit großen Karrieremöglichkeiten innerhalb einer globalen Organisation.

Mein Kunde sucht aktuell einen



Ihr Aufgabengebiet:

* Betreuung der Kunden im Bereich Qualität
* Systematische Reklamationsbearbeitung (Complaint Management/Capa)
* Durchführung von Validierungen
* Begleitung von internen und externen Audits



Sie bringen mit:

* Für diese Position suche ich eine dynamische, flexible und kommunikative Persönlichkeit, die über folgende Qualifikationen verfügt:
* Abgeschlossenes Studium als IngenieurIn oder TechnikerIn
* gute verhandlungssichere Englischkenntnisse in Wort und Schrift
* Kenntnisse im Qualitätsmanagement
* 3 - 5 jährige Berufserfahrung im Medizinbereich mit GMP-Erfahrung und/oder in der Kunststoffbranche
* Freude an komplexen Problemstellungen und sind es gewohnt, selbstständig und sehr präzise zu arbeiten
* Freude am Kontakt mit internen und externen Kunden.





Es erwartet Sie:

* Ein vielseitiges und anspruchsvolles Aufgabengebiet in einer zukunftsorientierten Branche mit hochmodernen Technologien
* Zeitgemässe Anstellungsbedingungen in einer wachstumsorientierten Unternehmensgruppe, in welcher berufliche Förderung und Weiterbildung grossgeschrieben sind



Mein Name ist Jennifer Herter, ich bin auf den Bereich Quality Assurance Recruitment fuer Medical Devices hier in der Schweiz spezialisiert und betreue verschiedene Unternehmen bei der Besetzung von Festanstellungen. Sollte Ihnen diese Position zusagen oder eine aehnliche, schicken Sie mir bitte Ihre Bewerbung, bitte in Word Dokumenten, an j.herter(at)realstaffing.com oder kontaktieren Sie mich unter +41 43 50 80 97 2.To find out more about Real Staffing please visit www.realstaffing.com
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