Sr. Manager, Clinical Affairs

REVA Medical   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 237 days ago

This job is no longer available.

Responsible for the operation and execution of international and domestic clinical trials that conform to all regulatory requirements. Develop protocols, investigator brochures, and other study related documents.Manage clinical investigators, Clinical Resource Organizations (CROs), internal support staff and data management resources to optimally execute established clinical research plans in achieving high caliber clinical research. Conduct and manage clinical data analysis in support of regulatory submissions, including performing internal clinical data analysis, working with study core labs, managing CEC and DSMB committees, overseeing internal data management staff and authoring clinical study reports.

The ideal candidate will have a Bachelor’s degree or equivalent experience with a minimum of 7-10 years medical device clinical trialexperience. Prior experience with Class III implantable cardiology devices required.