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Details
Clinical Development Lead
Reference: | SCAYEG-710603 | Location: |
Dublin |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
Clinical Development Lead
Our client, a clinical stage medical device organisation are currently recruiting a Clinical Development Lead to join their team on a permanent basis. This is a very exciting opportunity to join a passionate and driven team. As Clinical Development Lead you will lead the execution of the company’s clinical development and to manage, plan and execute the company’s clinical programme, with specific focus on patient recruitment for clinical trials.
Responsibilities
- Facilitating and developing the design, planning and execution of the company’s clinical programme with specific focus on managing recruitment to clinical studies
- Identify opportunities for increasing recruitment to clinical trials across the company’s portfolio; discuss with relevant stakeholders and responsible for the implementation of agreed recruitment initiatives
- 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)
- Maintain 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
- Conduct briefing and technical meetings for internal and external representatives
- Forecast 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
- 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’s QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives
- Willingness to travel to complete work related activities
- 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
- Excellent written and verbal communication skill
Project Manager Scientific Diagnostics Quality Engineering Supply Chain Product Development Engineer Allied Healthcare IT Supply Chain Chemistry Biotechnology Dublin Medical Device Microbiology Manufacturing Executive Cork Sales and Marketing Medical Affairs Limerick Life Science Biopharmaceutical Scientist Validation Engineer Pharma Sales Quality Control PhD Clinical Research Mayo Pharmaceutical Sales and Marketing Packaging Engineer Laboratory Scientist Engineering Academic Cork City Connected Health Academic Quality Assurance
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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