Sr. Manager, Clinical Data Management
Sr. Manager, Clinical Data Management
The Data Science and Innovation Department is seeking a Sr. Manager, Clinical Data Management to oversee the day-to-day management of clinical data for global clinical studies. The Clinical Data Manager works with the Clinical Project Team on studies and is the point of contact for all data management (DM) responsibilities. This person is responsible for study database design, data transfers from all third-party vendors and execution of the Data Management Plan, ensuring that all captured data follow the requirements outlined by the protocol and study plans. In addition to being responsible for the successful management of data from individual trials, the CDM will contribute to strategic efforts to harmonize data across trials to enable its seamless re-use for planning future trials.
- Serves as primary DM contact in assigned studies for data management tasks from database development, data review and cleaning to database lock and study archive
- Oversees the vendors responsible for all Data Management activities and supply study data, inclusive of a Functional Service Provider and CRO
- Supervises the development of data management plans, data entry guidelines, data validation specifications, metrics/dashboard reports and other documents as required. Ensures the data management activities are executed according to the Data Management Plan
- Supports database development activities and oversees CRF/database amendment and change control process
- Reviews CRFs, data listings, study dashboard and data transfers to ensure all captured data follow the requirements outlined by the protocol and studies plans
- Oversees the generation of queries and the resolution of all data related issues prior to database lock
- Oversees reconciliations of all third-party data with EDC database and reconciliation of clinical and safety database
- Oversees the archive of data management related study documents. Maintains the Data Management section of the eTMF of assigned studies
- Supports the Clinical Project Team and department management in review of study budget, reporting study metrics and ensuring budget compliance
- Assists in developing standards for CRFs and external vendor data, including data validation and reconciliation specifications
- Minimum of five (5) years data management experience, including experience as a Lead Data Manager. Experience managing CRO and external service providers is preferred.
- Understanding of CDISC data standards (CDASH and SDTM) and electronic data submission requirements.
- Experience with at least one database management system. Medidata RAVE experience is preferred.
- Prior experience using eSource, ePRO, eConsent and IRT systems strongly preferred.
- Knowledge of ICH and local regulatory authority drug research and development regulations is preferred.
- Excellent communication and presentation skills.
- Accountable team player who is organized, efficient, and produces high-quality deliverables.
- Working knowledge of CDISC and medical terminologies.
- Attentive to details and able to independently overcome obstacles.
- Desire to work in a fast-pace, dynamic, technology-driven, innovative environment.
- Working knowledge of Good Clinical Practices as well as relevant guidance and regulations from regulatory agencies.
- Knowledge of latest development in clinical research, such as risk-based clinical monitoring.
Minimum of a bachelor’s degree, preferably in a life science. Relevant professional certifications, e.g., Certified Clinical Data Manager, a plus.
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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