Lead Clinical Data Manager

Responsibilities

• Oversee all data management CRO activities supporting company's clinical programs from database start-up through database lock and CSR/submission.
• Serve as primary point of contact with the DM CROs, 3rd party vendors and internal study teams.
• Develop study timelines and ensure all DM related deliverables are met.
• Develop the clinical database, including user requirements, eCRF, edit rules/checks, data validation and User Acceptance Testing.
• Create and implement oversight listings, reports, programming checks and/or patient profiles.
• Maintain internal Data Review Log and work with DM vendor to resolve issues.
• Review and approve various Clinical research documents (e.g., Protocols, Safety Monitoring Plans, Communication Plans).
• Analyze and report on data management performance metrics from study start to database lock.
• Troubleshoot data-related issues and implement lessons learned for process improvement.
• Prepare and oversee study audits/inspections both internal and external.
• Oversight of all DM documents in the TMF (Trial Master File) or eTMF.
• Create and maintain meeting minutes for internal DM lead meetings/decision logs.
• Develop, track, analyze and report on data management performance metrics from study start to database lock.

Requirements

• Bachelor's degree in a science related field and/or computer systems/IT background.
• At least 8 years data management experience in a pharmaceutical/Biotech or CRO company.
• Familiarity with CDISC/CDASH including the SDTM model.
• Familiarity with standard international coding dictionaries (e.g., WHODD, MedDRA).
• Familiarity with Pinnacle 21.
• Experience with Trial Master file (paper or electronic).
• Experience with various EDC software such as Medidata RAVE, Medrio, Oracle, Inform, Veeva CTMS as well as IXRS.
• Ability to handle multiple tasks and prioritize based on timelines.
• Strong organizational and project management skills.
• Strong experience with Microsoft Word, Excel, Power Point, and other Microsoft tools.
• Experience working with CROs and vendor oversight.
• Ability to interact effectively with various functions such as Clinical Operations, Medical, Regulatory, Safety, Quality Assurance, Programming, and Biostatistics.
• Excellent verbal and written skills, good organizational, interpersonal, and team skills.
• Must be able to work independently and report to the Director of DM, as appropriate.
• Critical thinking and problem-solving a must.
• Working knowledge of Good Clinical Practices, Clinical research, Clinical Trial process and related regulatory requirements and terminology.
• Knowledge of regulatory agency such as the FDA, EMA, PMDA and audit experience a plus.