Senior Clinical Data Manager

Job Summary

The Clinical Data Manager will oversee clinical data management activities for Oncology Pivotal Phase III trials from protocol concept review through completion of the clinical study report. This includes managing CRO outsourced trials, ensuring data quality and timeliness, and coordinating database live activities.

Responsibilities:

• Oversight of clinical data management execution for pivotal trial(s) with CROs.
• Accountability for ensuring data quality and meeting deadlines.
• Coordination of study start-up activities, including eCRF design and database build.
• Data review and cleaning to ensure high-quality data.
• Management of query flow and data imports/exports.
• Coordination of Medical coding and SAE reconciliation efforts.
• Development and implementation of QC plans for CDM deliverables.
• Generation of CDM metrics and identification of data trends.
• Reconciliation of safety and external data with CRF data.
• Review of Data Management documentation and assistance in development of quality objectives.

Requirements:

• Deep understanding of drug development processes, regulations, and industry standards.
• Strong leadership, communication, and problem-solving skills.
• Ability to work in a cross-functional team environment and meet deadlines.
• Excellent project management and organizational skills.
• Experience with clinical data management systems and proficiency in EDC/RDC.
• Knowledge of CDISC, SDTM, and other industry standards.
• CDM Certification (CCDM) is desirable.

Education:
Bachelor's degree or years pharmaceutical experience, including data management of Global Pivotal clinical trials.