Manager, Clinical Data Manager, Oncology

Key Responsibilities :

• Support all Data Management activities for assigned projects, utilizing both outsourced and insourced models.
• Serve as the Lead Data Manager or Support Data Manager on insourced studies and as the Oversight Data Management Lead or support on outsourced studies.
• Act as the Data Management subject matter expert on cross-functional teams, providing accurate updates, timelines, and proactive communication on all Data Management topics throughout the study lifecycle.

This includes complex risk assessment and mitigation planning, with consideration of cross-functional impacts.

• Lead and support Data Management start-up activities, including the development and review of protocols, EDC database development documentation, eCRF Completion Guidelines, Data Management Plans, and collaboration across functions.
• Ensure clinical and vendor databases meet the necessary requirements for analysis, including developing and maintaining Data Transfer Agreements and managing vendor data transfer workflows.
• Participate in all aspects of data cleaning and review, including routine cleaning, third-party data reconciliation, query management, metrics reporting, and cross-functional communication and documentation of data health.
• Review and contribute to cross-functional study documents, such as Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, and presentation slide decks.
• Maintain all Data Management documentation to ensure preparedness for regulatory inspections.
• Collaborate with internal and external stakeholders on data transfers and analytics activities.
• May develop, review, and revise SOPs, Work Instructions, and Templates.

Requirements :

Bachelor’s Degree or equivalent experience, with at least 4 years of experience in Clinical Data Management within a Pharmaceutical, Biotech, CRO, or Academic setting.

Oncology experience is preferred.

• Excellent verbal and written communication skills, with the ability to convey Data Management and EDC technical concepts to cross-functional groups.
• Highly organized, detail-oriented, and outcome-driven, with strong collaboration skills.
• Ability to prioritize and adapt to tasks in a fast-paced environment.
• Proven ability to manage multiple Data Management tasks across clinical studies at varying stages.
• Extensive experience with EDC systems, particularly Medidata. Skills should include iMedidata Cloud User and Site Administration, Rave Local Lab Administration, Rave Coder, RTSM or other IRT system integrations, Rave Safety Gateway, and Rave Imaging.
• Advanced knowledge of data collection and cleaning best practices.
• Strong experience in managing vendors and data transfer workflows.
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines, and a general understanding of industry data collection and reporting standards, such as SDTM and CDISC / CDASH.
9 days ago