To lead the execution of the Company’s clinical development and to manage, plan and
execute the Company’s clinical programme.
- Facilitating and developing the design, planning and execution of the Company’s clinical programme which includes ongoing and new observational studies as well as all interventional studies to required international standards
- Support clinical site selection process overseeing the assessment of sites i.e. sites are adequately staffed and trained to perform the required tasks (protocol adherence, data reporting requirements, IRB reporting, regulatory requirements).
- Maintaining professional and credible image with key physicians, clinical investigators and consultants, liaising with all these relevant stakeholders to ensure efficient and timely clinical study execution
- Conducting briefing and technical meetings for internal and external representatives
- Forecasts and manage study related finances within agreed budgets and communicate on project status to wider team
- Manage the Contract Research Organisation and independent contractors relevant to the execution of the clinical programme
- Manage and track study related activities in-house and at site to allow identification and mitigation of any study related issues in a timely and efficient manner
- Support the running of internal and external meetings as needed by the project.
- Other duties to include support the development of the technical documents, organising key publications and performing literature searches
- Identify potential areas for internal process improvement, propose and implement changes following consultation and agreement with all relevant stakeholders
- Engage with the Company QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives
- Medical or scientific education with qualification to master's degree level or higher.
- 6+ years' experience from similar positions in the clinical trials industry.
Project management qualification
- Good working knowledge of FDA and ICH/GCP and European Medical Device regulations and willingness to continuously expand medical, scientific, market, and industry knowledge
- Motivated, self-starter and an organized individual with strong scientific background with the ability to work in teams.
- Good interpersonal skills and the ability to build strong relationships with key stakeholders.
- Technically proficient with PowerPoint, excel, word and reference management tools.
For further details contact Tina at +353 1 2784701 or 087 6811990 or email to email@example.com. Thornshaw Scientific is a division of the CPL Group. www.thornshaw.com