Senior Clinical Data Manager

The Senior Clinical Data Manager is responsible for overseeing end-to-end data management for Convatec’s clinical trials, ensuring data integrity, accuracy, and compliance with GCP and regulatory standards.

Requirements

• Act as the main point of contact for all assigned Data Management activities from study start up to database lock as well as all related data management tasks in the electronic data capture system (Veeva Vault CDMS)
• Participate in protocol development activities for key areas for Data Management
• Review draft protocols and eCRFs for potential data collection and representation, database structure or database entry problems, review data listings and database to ensure all captured data follow the rules outlined by the protocol and DMP
• Lead EDC system design, CRF design, user acceptance testing (UAT), and edit check programming
• Prepare Data Management Plans (DMP), CRF completion guidelines, Data Management reports and other documents required for the preparation and completion of databases
• Performs and oversees data review to identify discrepancies, ensuring accuracy and consistency
• Prepare routine reports to ensure appropriate study oversight, such as missing data reports, subject status report, open query reports, etc.
• Be responsible for training clinical study staff, both internal and external on the use of the electronic data capture system
• Support in the development of local processes/SOPs to improve Data Management
• Collaborate with cross functional clinical team for ongoing study activities
• Work in conjunction with the assigned Statistician to ensure reliable datasets containing high quality data are provided for analysis
• Ensures all data activities adhere to ICH-GCP, FDA/ICH guidelines, and SOPs
• Mentors junior staff, manages timelines, and drives process improvements

Benefits

• Comprehensive benefits package
• Retirement savings plan with company match
• Time off to include: paid vacation, holidays, community service days, sick time, paid caregiver/parental leave and medical leave
• Health benefits for individuals, families, and domestic partners, including medical, prescription drug, dental, and vision coverage