Senior Clinical Data Manager
Syneron Candela is a global company that develops and manufactures aesthetic products, services and systems with three primary Global Business Units focused on hair removal, body and facial/women’s products that are sold primarily to plastic surgeons, dermatologists and spas. Syneron Candela employs approximately 800 employees with major R&D and manufacturing facilities located in the United States and Israel. APAX, a private equity company, took the company private in July 2017
Essential Job Functions
- Clinical sub-team team leader: works closely with the Clinical Trial Manager and is responsible for oversight and execution of data management activities for assigned clinical trials including data timelines and key deliverables
- Preparing, validating and maintaining clinical trialdatabases according to ICH/GCP guidelines and current regulatory requirements
- Leads in database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals.
- Develops and executes data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs, Data Management Plans (DMP).
- Responsible for executing or overseeing data cleaning activities: includes generating and managing clinical trial data queries, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events.
- Tracking and reporting data management project status. • Assisting in data system development initiatives and database integration projects. • Works directly with and oversees CROs and vendors for Data Management services.
- Provides input and participates in development of clinical study documents including protocol and monitoring plans.
- Bachelor’s Degree in science/Mathematics/Statistics, Master’s Degree preferred
- Experience minimum 5+ years in a medical device or similar industry