Manager, Data Management

AskBio Inc.•Durham, NC

6d•Onsite

About The Position

This role is a secondment opportunity at AskBio, available for a time period determined by leadership at both Bayer and AskBio, typically ranging from one to two years. This secondment offers a unique chance to broaden experience, expand knowledge, and contribute to AskBio’s mission of advancing gene therapy and improving patients' lives. The Manager, Clinical Data Management will provide oversight of all data management activities, whether outsourced to external suppliers or conducted in-house. This includes study set-up, conduct, and close-out, encompassing database design specification development, programming, User Acceptance Testing (UAT), deployment to research sites, data review, database lock, and data archiving, ensuring the quality and integrity of all databases used in AskBio sponsored trials. The position reports to the Senior Director, Data Management.

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

Nice To Haves

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

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