Clinical Project Manager
Expanding Life Sciences Client in Wexford, the ''Sunny South East'' of Ireland, have a requirement for a Clinical Project Manager. Exciting opportunity with excellent career development opportunities with this world-renowned Medical Device organization
What is in it for you?
- This is great opportunity to expand your skillset and grow your career in this fast moving, dynamic and agile business.
- Attractive salary and benefits package on offer together with a friendly, welcoming and collaborative working environment
- Remote Working available
- Onsite parking and canteen (remote working initially)
- Days role, flexitime available & half day on a Friday!
- Commutable distance from Kilkenny, Waterford, Tipperary or Wicklow.
As a Clinical Project Manager, you will be reporting to the Associate Director Clinical Affairs and will be responsible for the execution of clinical and PMCF studies while working with a cross-functional team in accordance with the highest quality standards. You will liaise with external service providers and manages sites for national & international clinical studies.
- Project management and organization of external service providers (e.g. CROs)
- Drive and coordinate site management for national and international clinical studies throughout study implementation, execution, and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution
- Support of new product development activities (e.g. development of clinical strategies) applying problem-solving skills to any issues with cross-functional study team
- Write study protocols, safety plans and reports
- Accountability for trial/regional enrolment strategy and execution; plan and coordinate vendor activities
- Writing and compilation of documents for regulatory submission during all phases of clinical development and the post-marketing period, such as EC Submissions, Clinical Study Protocols, Clinical Study Reports, Investigators Brochures, Periodic Benefit-Risk Evaluation Reports
- Writing and maintaining of documents required for EU MDR submissions, such as Clinical Evaluation Plans and Reports, Post-market Clinical Follow Plans and Reports in compliance with applicable regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG)
- Support international product registrations and regulatory audits.
- Relevant Degree qualification or higher
- Experience in clinical study protocols, clinical study reports in the Medical Device/Pharmaceutical industry
- A clear, concise scientific style of writing with the ability to successfully write document types with minimal supervision and provide input for improvement
- Proficiency in literature database searches. Basic knowledge of biostatistics and medical background/application
- Good attention to detail to provide high-quality results.
- Proactive personality and willingness to develop in a global company.