|Title:||Senior Manager, Clinical Affairs|
Seeking Senior Manager Clinical Affairs for Industry Leader!
We are a world leader and innovator of tissue-based diagnostic solutions for patients worldwide.
Passionately pursuing our mission to improve the lives of all patients afflicted with cancer, the people of our company discover, develop, and deliver medical diagnostic systems and biopsy based cancer tests that are shaping the future of healthcare. As the leading supplier of cancer diagnostic systems to the pathology market, we manufacture over 200 cancer tests with related instruments for 56 countries, and most importantly, for 4 million people afflicted with cancer yearly around the world. Our products provide healthcare professionals with a total solution for all critical steps involved in the analysis of tissue biopsies. This pioneering company also offers premier workflow solutions to improve laboratory efficiency and preserve patient safety.
Seeking a Clinical Affairs Senior Manager to join our successful team. Seeking an individual with knowledge of clinical studies, IVD and Medical device preferable, but open to pharmacutical studies as well.
Compensation: $120,000-$160,000 base salary plus 10% bonus, full benefits and matching 401k.
Actively participate on cross-functional project teams responsible for the development and commercialization of advanced staining products including, but not limited to antibodies, detection kits, molecular probes and special stains. Foster cross functional relationships to create a cooperative work environment in support of corporate goals. Acts as cross-functional liaison within lifecycle teams to ensure trials are in alignment across lifecycle teams.
- Manage day to day activities of all aspects of the external studies department for assigned projects including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams.
- Conduct ongoing clinical research for clinical trials, including planning, execution, and interpretation of research results.
- Manage clinical operation plan and establishes protocol documents as needed.
- Manage direct report CRAs including recruitment, training, coaching, assignments, coordination of workload priorities and performance management.
- Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment.
- Management of study staff including training.
- Develop and monitor budget.
- Monitor work to ensure quality, and continuously promote Quality First Time.
Keywords: Clinical Affairs, Medical Device, IVD, Invitro Diagnostics, FDA, CFR, Management, Manager, IDE, PMA, 510k