The Associate Director, Data Management will be responsible for leading the planning, oversight and implementation of data collection, cleaning and locking for clinical trials across multiple programs. The incumbent will lead a team in providing oversight of the development of documents for clinical research studies, including protocols, case report forms, and standard operating procedures and will play a critical role in selection of the CRO that is responsible for study implementation and execution of the supporting electronic data capture (EDC) system.
- Establish and lead Clinical Data Management function at Revance while overseeing CRO’s data management activities that support ongoing clinical programs
- Actively participate in Biometrics function to support key functions within Clinical Development group, including Clinical Operations and Clinical Science
- Lead development of Data Management Plan (DMP) across programs and maintain throughout lifecycle of study project to ensure DMP is followed according to study design and requirements.
- Review clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).
- Lead EDC database (DB) specification process internally
- Review / Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
- Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Reconcile electronic data transfers from vendor to Sponsor.
- Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
- Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
- Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
- Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB
- Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests, project plans, and/or eCRF development activities.
- Participates in the preparation and presentation of data, when applicable.
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
Required Education and Experience
- Bachelor or Master degree in a science related field.
- Established leadership presence and successful track record of building and leading teams
- At least Six (6) years data management and/or related work experience on Phase I- IV study trials in a pharmaceutical industry/clinical research company.
- Prior experience filing a BLA or NDA required
- Demonstrated leadership in a cross-functional team setting
- Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC, CTMS, RAVE
- Excellent verbal and written skills, good organizational, interpersonal, and team skills.
- Ability to think creatively to solve problems in a fast-paced environment
- Well-tested team player who drives for results
- Applicable knowledge working with other clinical databases such as Oracle Clinical, SAS, other.
- AE Coding, if applicable.
- Excellent technical skills with MS Word, MS Excel, MS Power Point, and/or RAVE
- Possess experience in Data Management Plan, Data Edit Check Standards
- Ability to prioritize and to manage multiple tasks as necessary.
- High customer orientation awareness and focus.