Lead Clinical Data Manager

Responsibilities

• Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements.
• Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection.
• Perform data entry and cleaning activities, including discrepancy management and query resolution.
• Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
• Collaborate with study team members to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for data review.
• Serve as a primary or backup resource for issues about data management.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the development and validation of data management software tools.

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, preferably in smaller biotech sponsor environment.
• 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.
• Experience in development, validation, execution, maintenance, documentation, and archival of clinical data.
• 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.