Lead Clinical Data Manager
Remote · United States
Job Summary
Lead Clinical Data Manager will own end-to-end clinical trial data management from study startup to database lock, including EDC build and UAT, data cleaning and reconciliation, query resolution, and database locks. Responsible for ensuring optimized data collection and access across EDC and non-EDC sources, and for CDISC-compliant databases. Acts as a key member of the Clinical Operations team, developing data management documentation (CRFs, data management plans, edit check specs, data transfer agreements), designing CRFs for EDC systems, performing data entry and cleaning, conducting data validation checks, and ensuring regulatory compliance (GCP, CDISC, ICH, 21 CFR Part 11). Collaborates across study teams to resolve data-related issues, generates data listings/reports for data review, and contributes to the development and validation of data management software tools. Requires a BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent, 5-7+ years in pharma/biotech data management, strong project management and stakeholder management skills, and knowledge of MedDRA/WHO Drug dictionaries and CDM platforms such as Zelta by Merative. Remote work option available.
Required Qualifications
- BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience
- 5-7+ years of data management experience in the pharmaceutical or biotechnology industries
- Strong expertise in project/program management including stakeholder management
- Knowledge of industry standards (CDISC, SDTM, CDASH)
- In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
- Proven ability to preemptively identify data and system issues and mitigate risks to data quality
- Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data
- Experience in development and implementation of Clinical data management standards and procedures
- Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug
- Prior experience with Zelta by Merative (formerly IBM) CDM platform preferred
Additional Requirements
- None specified
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