Generate Biomedicines
Senior Manager, Clinical Data Management
Generate Biomedicines, Somerville, Massachusetts, us, 02145
About Generate:Biomedicines:
Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities.
We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!
Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.
The Role:
This individual will play a critical role in ensuring high-quality data delivery by collaborating closely with internal teams and CRO partners. This is an individual contributor position 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 Requirements:
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 (Optional):
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 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.
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This individual will play a critical role in ensuring high-quality data delivery by collaborating closely with internal teams and CRO partners. This is an individual contributor position 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 Requirements:
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 (Optional):
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 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.
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