Medasense is looking for a Manager of Clinical Affairs
Medasense is growing rapidly and looking for a Clinical Affairs Senior Manager, preferably with experience in the medical device industry, to join our dynamic and fast-paced environment.
- Assumes overall responsibility for establishment and management of clinical studies including: study protocol (CRFs, ICF), agreements, investigator brochure and all other necessary documentation for study initiation.
- Ensures clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations (ICH-GCP regulations, 21 CFR).
- Supports clinical sites with preparation and submission of required documentation to Institutional Review Boards. Ensures maintenance of IRB approval throughout the duration of the study, and ensures compliance with national and international regulations.
- Provides training to clinical sites regarding protocol requirements, data collection.
- Conducts periodic site monitoring visits. Verifies data accuracy and as part of data management performs data entry/verification.
- Provides clinical status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, Investigators and senior management.
- Supports Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to development of clinical reports for 510(k)s/PMAs as applicable, and clinical expertise related to FDA submission questions.
- Support in scientific and marketing publications
Desired Skills and Experience
- 10 year’s experience in medical device industry
- Strong knowledge of GCP and other regulatory requirements
- Excellent oral and written English language skills
- Overseas travel 30-40%
- /M.Sc. in life science/medical science
- Good analytical skills
- Leadership and management skills
Please submit your resume to: JobsClinical@nullmedasense.com