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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Development Lead


Reference:SCAYEG-710603 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Trials Advisor

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
Requirements
  • 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
For more information contact Sinéad Cullen on +353879500821 or [email protected]