Manager Clinical Data

Responsibilities

• Oversee end-to-end clinical data management activities for assigned studies, from study start-up through database lock.
• Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers.
• Review and contribute to key study documents, including data management plans, edit check specifications, CRF completion guidelines, data transfer agreements, and data review plans.
• Support CRF design, database build, user acceptance testing, and EDC system validation activities.
• Ensure timely data cleaning, query management, reconciliation, coding, and database lock activities.
• Coordinate external data transfers and reconciliations, including laboratory, pharmacokinetic, biomarker, imaging, safety, and IRT data.
• Partner with Clinical Operations and study teams to identify data quality issues and drive resolution.
• Support medical coding activities using MedDRA and WHODrug, as applicable.
• Contribute to clinical data review meetings and help prepare data outputs for internal decision-making.
• Maintain data management documentation in compliance with GCP, ICH guidelines, SOPs, and regulatory expectations.
• Contribute to process development and continuous improvement as the company scales its clinical operations infrastructure.

Requirements

• BS/MS degree in life sciences, data sciences, health sciences, or a related field.
• 8+ years of clinical data management experience in biotech, pharmaceutical, CRO, or related clinical research settings.
• Experience supporting oncology and/or immune disease clinical trials.
• Strong working knowledge of EDC systems such as Medidata Rave or similar platforms.
• Experience managing CROs and external clinical data vendors.
• Familiarity with clinical trial data standards, including CDISC, SDTM concepts, and database lock processes.
• Understanding of GCP, ICH guidelines, regulatory requirements, and clinical trial documentation standards.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced environment.
• Excellent communication and cross-functional collaboration skills.
• Experience in a small biotech or emerging pharmaceutical company.
• Experience with early-phase oncology trials, dose escalation, expansion cohorts, and complex biomarker-driven studies.
• Familiarity with molecularly targeted therapies, protein degradation, or immune-mediated disease programs.
• Experience with external data types such as genomics, biomarkers, PK/PD, central imaging, and specialty labs.