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Senior Clinical Research Physician

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Senior Clinical Research Physician – Ref NJ 13446

This is an excellent opportunity for a qualified GMC registered physician with some clinical research experience to work for a leading global CRO that provides a comprehensive range of services in Phase I-IV clinical trials to the pharmaceutical, biotechnology and device industries. The Senior Clinical Research Physician will join the company’s Medical Affairs Department in Eastleigh, Hampshire.

JOB ROLE: This role provides the necessary support to Company Project Teams on medical issues and input into their activities to ensure that projects of all phases (1-4) are conducted according to the highest ethical principles and in compliance with applicable legal and regulatory standards. He/she also provides medical consultation to company and sponsor team members for project related safety and medical issues.

PRINCIPAL ACTIVITIES & RESPONSIBILITIES include:
• Providing medical consultation on clinical studies including:
o Serious Adverse Event reporting to sponsors and regulatory authorities.
o Communication of safety issues to the Director of Medical Affairs and sponsors.
o Central lab report review, and CRF safety review.
• Providing medical training for the following areas:
o Company clinical staff in general medical issues.
o Investigator meeting presentations.
o Ongoing training for project teams in therapeutic areas.
• Reviewing and approving protocols, case report forms, informed consent forms (when applicable), and miscellaneous study documentation.
• The review of final study reports.
• Assisting with review of new tracking systems and databases as appropriate.
• Assisting with review and approval of Serious Adverse Event narratives.
• Consulting with Company Regulatory Affairs with regard to reporting of events.
• Preparing draft safety study specific procedures.
• Direct code-break activities (as appropriate).
• Final review and approval of coding (as appropriate.)
• Line management of DSAs as appropriate.

QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
• Medical Degree and broad based post-graduate experience
• GMC Medical registration is essential.
• Significant experience in a relevant clinical research role is preferred.

PERSONAL SKILLS & ATTRIBUTES:
• Excellent verbal and written communication skills
• Excellent presentation skills
• Good computer skills (MS: Outlook, Word, Excel)
• Ability and willingness to travel approximately 10% of the time or as required

BENEFITS OF THE ROLE: This Company has been nominated as a “top CRO” on 20 out of 25 site relationship attributes by pharmaceutical media company Thomson CenterWatch. They have an outstanding track record with a style of work that has been rated as the highest in the in the industry. They believe that their staff are their most vital asset and are committed to providing all the assistance and support you require to enable you to reach your goals and develop your career as far as you want it to go. Salaries are competitive and they offer an excellent benefits package including financial and long service awards.

Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors with a glowing reputation in the industry. For applications please email your CV to: stella@fforde-management.com or speak to our specialist consultant, Stella Daniel who will be pleased to give you further information and advise on your personal career needs. Tel: +44 (0)1273 222957
Visit our website at www.fforde-management.com

KEY WORDS: Senior Clinical Research Physician, Medical Doctor, MD, GMC Registered, Clinical Projects, Clinical Trials, Phase I-IV, Clinical Studies, Drug Safety, Clinical Safety, SAE Reporting, Safety Reviews, Medical Training, Protocol Review, Line Management, Medical Degree, CRO

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