Senior Clinical Data Manager - Cambridge, MA
The Clinical Data Manager will be responsible for the clinical data management (CDM) activities for the entire life cycle of Oncology Pivotal Phase III trial(s) from protocol concept review through completion of the clinical study report.
- Proactively oversee CDM execution of CRO outsourced pivotal trial(s).
- Accountable and responsible for ensuring data quality and timeliness of study related CDM deliverables.
- Coordinates study start-up activities; review and sign off of eCRF, eCRF completion guidelines, Data Validation (edit check) Specifications, data management plan (DMP), data review guidelines (DRG); coordinates database live activities; tests/accepts clinical database for EDC studies.
- Conducts peer review, develops and implements QC plan for CDM deliverables from internal and functional service providers (CROs), including but not limited to: eCRF design, Data Validation Specifications, Database build, UAT and validation documentation.
- Data review and cleaning to ensure data quality. Executes DRGs and manages query flow.
- Data imports/exports with external data providers.
- Coordinates Medical coding and SAE reconciliation efforts.
- Generates and reviews CDM metrics for study management team (SMT); identifies and communicates data trends to SMT; reconciles safety and other external data with CRF data; reviews any study-specific quality objectives and ensures these are reflected in the study Data Management Plans.
- Manages data entry personal and manages CRF paper tracker in some instances
- Identifies process gaps in CDM area and makes recommendations for improvement. Creates and maintains SOPs related to CDM activities.
- Effectively manages assigned projects by adhering to established timelines and deliverables.
- Reviews all required Data Management documentation for projects.
- Assists in the development of quality objectives for each project; Adoption and implementation of established standards and processes; and identifies areas where new standards are needed.
- Full Knowledge of the drug development, study conduct processes, regulations related to Data Management and clinical research such as CFR Title 21, ICH Guidelines, EU Directives, GCP and relevant regulatory compliance.
- Exhibits strong leadership, communication (written and oral), interpersonal communication skills, logical thinking, attention to detail and problem solving abilities.
- Experience with clinical data management systems, proficiency in EDC/RDC (e.g. RAVE, Inform, Oracle Clinical), experience in basic SAS / SQL programming, and an understanding of CDISC, SDTM and other industry standards, experience with reporting tools like J-review is a plus.
- CDM Certification (CCDM®) is desirable.
- Bachelors degree or 6+ years pharmaceutical experience, including data management of Global Pivotal clinical trials.
If you or a Clinical Data Manager you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role. Thank you!
Sthree US is acting as an Employment Business in relation to this vacancy.