Manager, Clinical Data Management

Role Overview

• Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
• Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data
• Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock) for multiple studies across therapeutic areas and/or indications
• Develop and manage data management timelines to ensure study goals and activities are met
• Oversee External Data Management activities by providing project level support of External Data Management tasks (development of Data Transfer Plans, coordination of file transfers to meet study deliverables etc.)
• Anticipate obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly in order to meet team goals
• Manage the development and finalization of CDM documents to be filed in the eTMF
• Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness
• Serve as a primary point of contact for internal and external study team members in relation to all Data Management activities
• Ensure completeness, accuracy, and consistency of clinical data and data structure across all projects on an ongoing basis
• Responsible for data review, query management, and metric report delivery to study teams
• Coordinate study timelines and database snapshots for analysis and safety review meetings
• Participate in and/or represent CDM during internal audits as well as Health Authority audits and inspections
• Participate in the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM
• Participate in CDM and cross-functional initiatives
• Proactively provides input to continuous improvement activities within Clinical Data Management and provides the relevant support for implementation
• Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks.

Requirements

• MS/MA in life sciences or related discipline and 4+ years of experience in Data Management OR BS/BA in life science or related discipline and 6+ years of experience in Data Management OR High School degree and 10+ years of experience in Data Management
• Experience as independent lead in managing clinical data management deliverables for regulatory filings
• At least 6 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices
• Experience in Industry Standards Guidelines (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models
• Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, etc.)

Tech Stack

• Oracle

Benefits

• Eligible for discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)
• Paid time off
• Company-sponsored medical, dental, vision, and life insurance plans