Principal Responsibilities
- Serves as primary DM contact for assigned studies, including representation on project teams and works with CRO’s performing data management tasks for assigned study
- Leads and performs Clinical Data Management Tasks for assigned studies in accordance with SOP’s and policies and practices
- Monitors data clean-up process performed by CRO’s from study start-up through data archiving
- Provides data for analysis
- Manages activities including: medical coding; developing data validation checks and managing database snapshot
- Prepares and distributes project status reports to project team and management
- Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with SOP’s
- Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF
- Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities
- Contributes to upkeep DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization
- Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures.
- Adheres to procedures surrounding retention of data, records, and information for clinical studies
Minimum Qualifications
- Bachelor’s degree in life sciences, math, computer science or related field required
- Master’s degree in life sciences, math, computer science or related field preferred
- Minimum of four to six years clinical data management experience
- Prior experience with biostatistics and SAS programming preferred
Skills and Abilities:
- At least four (4) years data management and/or related work experience in a medical device or pharmaceutical industry/company.
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC and CTMS.