Position Summary We have an opportunity for
Manager, Clinical Data Management to join the AskBio team in our RTP, North Carolina, location and be part of our continued success!
The
Manager, Clinical Data Management, provides oversight of all data management activities outsourced to external suppliers and/or conducted in-house, from study set-up, to conduct and close out. including but not limited to database design specification development, database design programming, database User Acceptance Testing (UAT), database deployment to research sites, data review and database lock and data archiving. Therefore, ensure the quality and integrity of all databases used in AskBio sponsored trials.
This position will report to the Senior Director, Data Management.
Job Responsibilities- Ensure that end-to-end Data Management activities are conducted in accordance with high ethical and quality standards, all applicable GCP regulations and company procedures
- Provide oversight of all data management activities outsourced to external suppliers and/or conducted in-house, including but not limited to Data Management Plan, database specification development, database design programming, database User Acceptance Testing (UAT), database deployment to research sites, data review, coding and database locks
- Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Serve as the DM point of contact for internal and external study team members with minimal oversight from senior data management resources
- Provide strong quality and project oversight over third-party vendor responsible for data management deliverables
- Take a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (Non-EDC Data)
- Represent DM on cross-functional project teams & submission teams
- Provide support for Health Authority inspections and audits
- Effectively manage changes to database design and data management requirements as necessary due to protocol amendments and changes to overall clinical development programs
- Develop, troubleshoot, and maintain complex programs and utilities leading to database design, creation, validation, & use as well as clinical trial statistical analysis
- Participate in the development of departmental standard operating procedures, working procedures and guidance documents
Minimum Requirements - Bachelor's degree in life sciences, statistics, biostatistics, mathematics, computer science, biotechnology or related field with a minimum of 6 years' clinical trial related data management experience
- Prior use of and/or familiarity with clinical trial database packages such as Veeva EDC, Medidata Rave
- Significant knowledge of the drug development process, clinical trial methodology, data management & statistics and relevant regulatory requirements for drug approval
- Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise
Preferred Education, Experience and Skills- Good knowledge of CDASH® standards and how they support CDISC® standards (SDTM). Hands on experience of confirming database design and DM principles are consistent with all types CDASH® of and their support of SDTM
- Experience managing multiple sources of data
- Experience identifying and mitigating potential risks in the DM space; problem resolution skills to solve errors/inconsistencies found in data processing to reduce risk to data integrity and validity
- Experience in managing gene therapy studies
- Excellent verbal and written communications skills; able to communicate proactively and effectively
- Utilizing and developing SAS, SQL, Power BI, Excel and other analytical tools to support clinical data review, identifying data trends and discrepancies, and monitoring study performance metrics
