Clinical/Medical Affairs Manager
Location: Greater Philadelphia Region
Contact: Donna Gross, email@example.com
Clinical/Medical Affairs Manager | Medical Device Company
This search is being conducted on behalf of our Medical Device client who has FDA approval for the treatment of depression. This treatment has the CE mark of approval and is used globally.
In this role, one will be a representative of the medical operations department who interacts with customers regarding Investigator Initiated Trials and Safety surveillance. The primary responsibility of this position is to provide scientific and clinical expertise support. One will report to the Director of Medical Operations.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
- Privately held medical device company with 120 employees.
- The environment is high-energy.
HIGHLIGHTS OF RESPONSIBILITIES:
- Performs clinical literature research regarding TMS and psychiatric disease states.
- Summarizes key papers and review with key medical and other company personnel.
- Summarizes papers associated with studies for background.
- Oversees post market surveillance program through coordination of the safety committee to include:
- Owner of agenda and minutes.
- Literature searches for safety surveillance.
- Coordination of medical complaints handling to closure.
- Clinical Evaluation Reporting.
- Manages investigator-initiated trial programs.
- Coordinates new proposals through review to completion.
- Interacts with investigators to discuss their research plan to understand and explain.
- Trains site to study responsibilities.Assists with sponsored clinical trial management activities.
DESIRED SKILLS AND QUALIFICATIONS:
- Bachelor of Science degree required; preferable in Life Sciences or Nursing.
- 5+ years of relevant Medical Information or Clinical Research experience.
- Proficient in medical information processes and industry standards.
- Medical Device or Pharmaceutical experience.
Donna Gross, Director Life Sciences Recruiting
Phone: 267-483-5233 x 101
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Warrington, PA 18976