Clinical Affairs Trial Leader
Tampa , FL 33601
Posted 2 weeks ago
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Corin, a rapidly growing orthopaedic medical device business, is currently looking for a Clinical Affairs Trial Leader with two direct reports who will be primarily accountable for clinical data requirements to support regulatory and other post-launch evidence needs in the US and Canada. As our Clinical Affairs Trial Leader you will conduct high quality clinical research in accordance with regulations and guidance and oversee local associated data management activities.
You will need to have knowledge of all applicable standards, regulations, and guidelines to comply with pre and post-market clinical evidence generation requirements.
As a Clinical Affairs Trial Leader you will ;
- Ensure clinical studies and data management activities in the US and Canada are conducted incompliance with Corin procedures, study protocols, and all applicable regulations and guidance or clinical studies, data management and data protection.
- Manage clinical studies (both company sponsored and Investigator initiated) as assigned interacting with investigational sites, vendors and cross functional teams.
- Propose and implement agreed process improvements in clinical study and data management.
- Supervise assigned data management staff to manage their assigned activities in a compliant manner, leading the performance management and supporting the on-going development of supervisee(s).
- Assist with the development of high quality clinical protocols, case report forms, regulatory documents and other clinical study related materials as needed.
- Contribute to clinical reports to support pre-market product registrations/submissions and applicable post-market activities in the US and Canada.
- Interface with surgeon investigators in preparation of abstracts, clinical papers, presentations.
- Participate in the submissions and review of newly proposed and ongoing clinical studies (both company sponsored and Investigator Initiated) in the US and Canada via the Clinical Review Committee.
- Establish and maintain good working relationship with internal and external stakeholders.
- Liaise with other internal departments serving on cross functional teams as needed.
- Report adverse events as required for Corin Vigilance and Product Complaints reporting.
- Undertake deputised duties as required.
As a Clinical Affairs Trial Leader you will be;
- Degree educated in a life science subject or equivalent.
- Detailed knowledge of regulations, standards and guidance pertaining to clinical research and data including the FDA regulations and Guidance, Declaration of Helsinki, ethics/use of human subjects, GCPs, HIPAA, applicable data management and data protection requirements.
- Minimum 5 years experience in medical device or pharmaceutical clinical research ideally including experience in orthopaedics and IDE clinical trials.
- Experience in mentoring or supervising colleagues or team members.
- Excellent written and verbal communication skills.
- Knowledge of MS Office applications including Word, Excel, PowerPoint.
- Highly detail oriented. Ability to multi-task in a fast paced environment. Ability to prioritize projects and delegate to team appropriately.