Clinical Project Manager, Cleveland, OH
Coordinates and implements low back pain and amputee clinical study trial activities.
- Coordinates and monitors studies to ensure compliance with protocols, regulatory requirements and Good Clinical Practices.
- Coordinates development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA. Reviews regulatory documents from sites.
- Develops standard operating procedures for clinical studies.
- Trains clinical site staff on study protocols, good clinical practices and use of investigational devices.
- Develops and implements data management methodologies.
- Develops and maintains planned communications with sites.
- Assists with the development, implementation and evaluation of research subject recruitment strategies to maximize enrollment and retention.
- Analyzes site strengths and weaknesses related to intended protocol and selection of qualified investigator and sites.
- BS degree or higher in Life Sciences or related technical or clinical field.
- Minimum of 5 years of clinical research experience with the design, management and conduct of medical device or drug related clinical studies.
- 1-2 years project management experience.
- Knowledge of FDA guidelines and Good Clinical Practices.
- Ability to travel up to 25% depending on the clinical studies.
Why Join Our Team?
- Excellent career opportunity in a rewarding medical device industry
- Small, collaborative office environment
- Competitive compensation and benefits
- Employee Wellness Program