Senior Clinical Data Manager

• 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 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.
• Develops/maintains CDM timelines for assigned studies with input from study team and all relevant functions.
• 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.
• Works well in a cross functional team environment with and ability to work in a team to meet timelines and achieve deadlines.
• Excellent project management, organizational, prioritization, and multitasking skills. Demonstrated ability to work independently.
• 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.
• Bachelor's degree or 6+ years pharmaceutical experience, including data management of Global Pivotal clinical trials.
• Oncology, CRO, CLINICAL TRIALS, CDM, CLINICAL DATA MANAGEMENT.

Katalyst Healthcares & Life Sciences