Clinical Project Manager - Remote

An opportunity has opened for an experienced Clinical Project Manager to join a medium sized Medical Devices company in a permanent, home based role in the UK working on complex Class III device studies. This opportunity would suit an innovative individual who is looking to work in a varied position as it's a small team environment, so when the team does grow, you'll have the chance to progress quickly.


Principal Responsibilities

• Develop clinical study design concepts in line with the requirements of the business plan and work with internal and external resources to refine these plans into comprehensive clinical projects with associated implementation plans and budgets.
• Provide leadership of agreed clinical studies working with internal and external resources to secure timely and successful conclusion within the allocated budget and resources.
• Develop clinical study protocols and study related documentation and ensure the development, production and filing of required documents is managed within the Quality System requirements.
• Proactively identify sites for clinical investigation and conduct feasibility, qualification, initiation and visits as required to assess and monitor compliance.
• Ensure that investigators and investigational site staff are provided with clinical support as required to achieve the highest standard of proficiency in use of the Company's products and compliance with the study protocol(s).
• Escalate medical issues to the Director, Clinical Operations.
• Establish Data Monitoring Committees, prepare and conduct regular meetings.
• Ensure that internal and external resources applied to each clinical project are managed efficiently and with effective oral and written communication throughout the project team.
• Contribute to the ongoing scientific review of the clinical database and draft or contribute to the preparation of manuscripts for regulatory and publication purposes.
• Provide Clinical Affairs Input to regulatory submission documents (e.g. Clinical Evaluation Report, Periodic Safety Update Report, Post-Market Clinical Follow-up) and the risk management file.
• Set-up and maintain external Core labs.

Education & Training

• A Bachelor's degree
• Strong knowledge of the clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

Experience

• A minimum of 5 years clinical study experience, ideally in the medical device sector.

What's on offer? Between £65,000-£75,000 basic salary + 15% bonus + much more.

• If you are having difficulty in applying or if you have any questions, please contact Joseph Dwyer-Canton. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
  Proclinical Staffing is an equal opportunity employer.
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