External Data Management & Biosample Operations Lead

Role Summary

The External Data Management & Biosample Operations Lead is a multi-disciplinary role requiring deep data management expertise, clinical trial operations knowledge, and understanding of central lab processes and LIMS. The role coordinates cross-functional teams to ensure timely collection and integration of biosample and external data into the clinical database, delivering high-quality study data for analysis and reporting. This position reports to the Head of Data Management and can be located at the New Haven, CT headquarters or remotely within the U.S.

Responsibilities

• Serve as the subject matter expert and main point of contact for external data management activities across studies and data interchanges with the clinical database.
• Oversee vendor oversight of central labs and biosample movements between central labs and analyzing labs.
• Manage external data transfer agreements and data interchanges to ensure alignment with protocol and analysis requirements.
• Develop and implement standardized data flows and SDTM-compatible data integrations for a wide variety of data types.
• Provide ad hoc support for technical data management activities, including EDC testing, SDTM compliance reviews, data file format reviews, and analytics verification.
• Oversee DM activities performed by DM CROs and vendors; review and approve DM-related documentation.
• Support clinical study data review using JReview, including user administration, training, and maintenance of report objects and data listings.
• Provide operational support for Clinical Study Teams and Biomarker Subteam; assist with SOPs and quality document development.
• Review vendor contracts and work orders; oversee central lab vendors, LIMS, and related study documentation.
• Act as POC for central lab quality events and incidents; supervise analyzes lab vendor activities and data transfers.
• Track PK biosample movements from Central Lab to PK Lab and ensure biosample results are available for cohort decision-making.
• Oversee biosample management and movements, including long-term storage/biorespository transfers; assess sample loss risk and mitigate issues.
• Develop and maintain SOPs, work instructions, and other quality documents related to data and biosample management.

Qualifications

• 10+ years of clinical data science, data management, biometrics, and clinical operations experience in a pharmaceutical/biotech setting.
• In-depth data management expertise and external data management experience.
• Strong understanding of central lab/analyzing lab processes and LIMS, including biosample requisitioning and accessioning.
• Extensive experience with clinical data interfaces and data exchanges with CROs and external vendors.
• Experience working with clinical CROs and external vendors; ability to manage budgets, goals, risk, and vendor performance.
• Proficient with relational databases, EDC systems (e.g., Rave), sponsor acceptance testing, and study management tools.
• Proficient with J-Review; ability to create data reviews, listings, profiles, and visualizations.
• Strong understanding of EDC data collection, external data loading, and protocol requirements; familiarity with CDASH, CDISC, and external Data SDTM standards.
• Knowledge of GCP-ICH, SOPs, regulatory requirements, and Good Data Management Practices, including 21 CFR Part 11 and GxP systems.
• Strong problem-solving, communication, and cross-functional collaboration skills; ability to influence decisions.
• Must be legally authorized to work in the US without employer sponsorship now or in the future.
• Ability to work in a home office environment and maintain availability during standard business hours.

Education

• Bachelor’s degree in quantitative, scientific, or health-related field required.