Job Function: Manage/perform clinical research activities and develop clinical strategies for worldwide clinical trials for a variety of medical devices, biologics, technologies, and clients.
General Functions:
- Manage all activities associated with executing clinical trials, including investigator selection, protocol development, contract negotiation, IRB/EC approvals, monitoring, data management, data analysis and clinical study reporting.
- Direct clinical research projects, ensuring studies are executed within time and on budget.
- Trouble shooting and problem solving leadership.
- Provide clinical trial summaries for relevant regulatory submissions.
- Collaborate with Regulatory Affairs in preparing clinically-related regulatory documents.
- Provide clinical input to product development teams, as appropriate.
- Represent clinical research on project teams and establish appropriate clinical strategies.
- Review any clinically related advertising and promotional materials, as appropriate.
- Manage/maintain clinical study records.
- Manage/generate departmental procedures.
- Perform searches/analyses to address specific clinical questions or issues.
- Participate in due diligence activities as needed.
- Advise clients on clinical protocols, clinical reports, clinical strategies and GCP compliance issues.
- Coach clinical staff.
Expected Areas of Competence:
- Demonstrated knowledge and experience with U.S. and international device clinical regulations, including ICH, FDA CFR, GCP and ISO-14155.
- Demonstrated success in setting clinical strategy and in executing worldwide clinical studies, particularly those involving complex issues.
- Detail-oriented with ability to accomplish objectives with minimal supervision.
- Competence in applying scientific principles and logical thought processes in preparing clinical documentation.
- Ability to interact effectively in a team environment.
- Proficiency in basic personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, etc.
- Advanced written and oral communications, technical writing and editing skills.
- Strong organizational skills, able to manage multiple projects and clients with shifting priorities.
- Proficient knowledge of medical terminology, practices and procedures.
- Expertise with GCP compliance, including BIMO audits.
- Knowledge of clinical trial strategy and study design, statistical methods and outcomes research.
- Self-directed individual, able to take the initiative and handle ambiguity.
- Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills.
- Ability to travel (approximately 30%).
Education, Training and Experience Required:
- Bachelor’s degree (technical). Technical degree defined as medical, biological sciences or related medical/scientific field
- More than ten years Clinical Research experience directly supporting clinical research in the medical device sector. Minimum three years experience with Class III devices.
- More than 3 years people management experience.
- ACRP certification a plus