Manage and oversee CROs/vendors in clinical data management on clinical trials within assigned program
Oversee the data management activities and deliverables from EDC build to final database lock and their timelines for assigned studies
Perform detailed reviews of data management specific plans and database specifications
Perform User Acceptance Testing (UAT) on EDC, IRT and eCOA systems
Develop study metrics reports and other reports as needed
Work with vendors to set up and review data transfer specifications
Oversee vendor data reconciliation
Lead the creation of data review plans
Collaborate and communicate regularly with internal and external team members

Bachelor’s degree required, at a minimum
7+ years of relevant industry experience in clinical data management
Proficiency in EDC systems (i.e. Medidata Rave) and other integrated clinical systems (e.g., IxRS/IRT)
Excellent project management skills
Great attention to detail with excellent interpersonal, organizational, written and verbal communication skills
Working knowledge of ICH GCP and other regulatory guidance documents
Working knowledge of CDISC/CDASH, GCDMP and other clinical data standards

Senior Manager, Clinical Data Management

Key skills