Lead Clinical Data Manager

Responsibilities

• Develop and maintain data management documentation including CRFs, DMPs, and data transfer agreements
• Design case report forms (CRFs) for electronic data capture (EDC) systems
• Perform data entry, cleaning, discrepancy management, and query resolution
• Conduct data validation checks and implement quality control measures
• Collaborate with study teams to resolve data-related issues
• Generate and review data listings, summaries, and reports
• Ensure compliance with GCP, CDISC standards, and relevant regulations
• Contribute to the development and validation of data management software tools

Requirements

• BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics, or equivalent
• 5-7+ years of data management experience in pharmaceutical or biotechnology industries
• Expertise in project/program management and stakeholder management
• Knowledge of CDISC, SDTM, and CDASH standards
• In-depth understanding of ICH, GCDMP, and 21CFR Part 11 guidelines
• Experience with web-based EDC and medical coding dictionaries (MedDRA, WHO Drug)

Preferred Qualifications

• Experience in a smaller biotech sponsor environment
• Prior experience with Zelta by Merative (formerly IBM) CDM platform

About the Company

Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies to provide better survival rates with fewer risks for patients fighting blood cancer.