Responsible for operations of clinical trial conduct in support of registration of products. Assist Director with managing vendors, CRAs, and contractors. Provide operational oversight of CROs for compliance and performance.
- Perform day to day clinical project management functions, including weekly project team meetings, study performance metrics creation, review and management.
- Interface for multiple vendors (CRO, laboratories, and packaging/supplies).
- Maintain and manage Trial Master Files for studies.
- Create and approve project-specific work practices and documents in conjunction with the CROs, in-house staff, or contractors.
- Manage financial aspects of clinical projects including CRO, vendor and site payments, tracking and processing of payments.
- Ability to write Study Protocols and Final Study Reports and provide input on Statistical Analysis Plans, Data Management Plans, and other required documents.
- Prepare updates and metrics reports for ongoing studies.
- Participate in cross functional core team meetings as the department representative.
- Provide monitoring oversight for the project through review of monitoring metrics, monitoring report review and approval, and co-monitoring.
- Able to perform Clinical Research Associate job functions such as site qualification visits, site training visits, and monitoring visits.
- Manage the data management process internally or with vendors.
- Participate in both external and internal inspections and audits.
- Assist with generation of clinical portions of regulatory submission documents.
- Participates in preparation of regulatory submission responses to FDA inquiries.
- Participate in clinical staff hiring decisions, training, goals setting, performance monitoring, and performance reviews for clinical staff.
- Work with direct report CRAs to set individual goals in order to achieve corporate strategic imperatives.
- Monitor staff performance and provide constructive feedback and coaching.
- Knowledge of Code of Federal Regulations, Good Clinical Practices, and FDA guidelines pertaining to medical devices and biologics.
- Knowledge of EU Medical Device and In Vitro Diagnostics Regulations.
- Outstanding organizational and time-management skills such as prioritizing/organizing to meet deadlines of multiple projects with overlapping deliverables.
- Excellent oral and written communication skills
- Advanced PC Skills (Microsoft Word, Excel and Power Point)
- Ability to travel up to 30%
EDUCATION AND/OR EXPERIENCE
- Bachelor of Science level education, preferably in a scientific or medical discipline.
- Minimum of 5 to 7 years of experience in the FDA regulated medical device or pharmaceutical industry, for sponsor companies or contract research organizations.
- Minimum two (2) years supervisory experience.