Clinical Data Manager
- Job Level:
Clinical Data Manager (CDM) is responsible for providing data management support for the clinical development plan. This will be done while maintaining high quality standards and in compliance with Regulatory Authorities’ regulations / guidelines and SOPs / WPDs. The CDM will be the lead data manager for one or more studies based on study start up, maintenance or database lock phase.
- Responsible for the oversight of data management CRO activities supporting clinical programs from database start-up through database lock and CSR/submission.
- Serves as a primary point of contact with the DM CROs, 3rd party vendors, and internal study teams.
- Works with internal team and DM CRO to develop study timelines and ensures all DM related deliverables are met.
- Oversees the development of the clinical database (DB), including user requirements, edit rules/checks, query logic, and data validation.
- Oversees the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, programable edit checks, and Data Management Plans DMP) Ensures compliance with these study documents.
- Participates in the review of Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Communication Plans).
- Works with the CRO to ensure the clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.
- Organizes study-specific meetings (e.g. Protocol Deviation review. Medical Data review).
- Develops, tracks, analyze and report, as applicable, on data management performance metrics.
- May assist in the preparation and oversight of study audits/inspections both internal and external.
- May help develop and/or revise Data Management SOPs, Work Instructions and templates/standards incorporating the industry’s best practices and any applicable Regulatory guidelines and requirements.
- Bachelor’s degree in a science-related field and/or computer systems/IT background.
Experience & Skills Required
- At least 5-7 data management and/or related work experience in a pharmaceutical company.
- Familiarity with CDISC/CDASH including the SDTM model.
- Familiarity with standard international coding dictionaries (e.g. WHODD, MedDRA)
- Experience with various EDC software such as Medidata RAVE, Medrio, Oracle, Inform.
- Ability to handle multiple tasks and to prioritize. Strong organizational and project management skills.
- Experience working with CROs and with vendor oversight.
- Ability to interact effectively with various functions such as Clinical Operations, Medical, programming, and Biostatistics.
- Experience with working on Phase I-IV study trials.
- Excellent verbal and written skills, good organizational, interpersonal, and team skills.
- 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.