Generate:Biomedicines
Senior Manager, Clinical Data Management
Generate:Biomedicines, Somerville, Massachusetts, us, 02145
Overview
Senior Manager, Clinical Data Management. This role supports clinical data management activities across the company’s portfolio, collaborating with internal teams and CRO partners to ensure high-quality data delivery. This is an individual contributor position suitable for someone who thrives in a fast-paced environment and brings strong operational experience in small biotech settings. Responsibilities
Serve as the primary data management representative on cross-functional study teams Lead the development, review, and maintenance of data management documentation, including Data Management Plans (DMP), CRF Completion Guidelines, and Data Review Guidelines Oversee user acceptance testing (UAT) of eCRFs and associated edit checks Conduct data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders Review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets Collaborate with CROs to manage timelines and deliverables for data management activities Contribute to database lock activities, ensuring audit readiness and data integrity Maintain and QC study-specific trackers and metrics dashboards Create and manage data deliverable timelines and tasks Review and provide feedback on vendor data transfer agreements, transfers and reconciliation Provide support to the Clinical Data Management Lead on study-related tasks and initiatives Ideal Candidate
BS with 8+ years or MS with 5+ years of clinical data management experience in CRO, pharma, or biotech settings Strong experience with Medidata Rave EDC systems and electronic trial master files (eTMF) Demonstrated knowledge of ICH/GCP, FDA regulations, and clinical trial processes Proficiency in industry data standards including CDISC, SDTM, and CDASH Prior experience collaborating with CROs on clinical studies Highly organized with excellent communication and interpersonal skills Experience in small biotech environments highly preferred Nice to Have
Experience supporting IND or BLA submissions Familiarity with data visualization or analytics tools Exposure to AI-enabled or digital trial approaches Why Join Us
Generate:Biomedicines is pursuing generative biology to create novel therapeutics and aims to transform patient lives. You will join a mission-driven team that values collaboration, innovation, and continuous growth, helping build scalable, digital-forward data practices in biomedicine. Equal Employment Opportunity
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Compensation
Base salary range provided reflects current estimates. Actual base salary will be based on factors including skills, experience, internal equity, education, and market dynamics. Eligible for an annual bonus, equity compensation, and a competitive benefits package. Salary range: $140,000 — $196,000 USD per year.
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Senior Manager, Clinical Data Management. This role supports clinical data management activities across the company’s portfolio, collaborating with internal teams and CRO partners to ensure high-quality data delivery. This is an individual contributor position suitable for someone who thrives in a fast-paced environment and brings strong operational experience in small biotech settings. Responsibilities
Serve as the primary data management representative on cross-functional study teams Lead the development, review, and maintenance of data management documentation, including Data Management Plans (DMP), CRF Completion Guidelines, and Data Review Guidelines Oversee user acceptance testing (UAT) of eCRFs and associated edit checks Conduct data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders Review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets Collaborate with CROs to manage timelines and deliverables for data management activities Contribute to database lock activities, ensuring audit readiness and data integrity Maintain and QC study-specific trackers and metrics dashboards Create and manage data deliverable timelines and tasks Review and provide feedback on vendor data transfer agreements, transfers and reconciliation Provide support to the Clinical Data Management Lead on study-related tasks and initiatives Ideal Candidate
BS with 8+ years or MS with 5+ years of clinical data management experience in CRO, pharma, or biotech settings Strong experience with Medidata Rave EDC systems and electronic trial master files (eTMF) Demonstrated knowledge of ICH/GCP, FDA regulations, and clinical trial processes Proficiency in industry data standards including CDISC, SDTM, and CDASH Prior experience collaborating with CROs on clinical studies Highly organized with excellent communication and interpersonal skills Experience in small biotech environments highly preferred Nice to Have
Experience supporting IND or BLA submissions Familiarity with data visualization or analytics tools Exposure to AI-enabled or digital trial approaches Why Join Us
Generate:Biomedicines is pursuing generative biology to create novel therapeutics and aims to transform patient lives. You will join a mission-driven team that values collaboration, innovation, and continuous growth, helping build scalable, digital-forward data practices in biomedicine. Equal Employment Opportunity
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Compensation
Base salary range provided reflects current estimates. Actual base salary will be based on factors including skills, experience, internal equity, education, and market dynamics. Eligible for an annual bonus, equity compensation, and a competitive benefits package. Salary range: $140,000 — $196,000 USD per year.
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