Senior Manager, Clinical Data Management

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. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.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 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.The Role: At Generate Biomedicine, our portfolio continues to evolve, and projects continue to move rapidly into clinical development creating greater complexity of collaboration, information sharing, and need for coordination. We are seeking a Senior Manager, Clinical Data Management to support clinical data management activities across our portfolio. 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.Here's how you will contribute:Serve as the primary data management representative on cross-functional study teamsLead the development, review, and maintenance of data management documentation, including Data Management Plans (DMP), CRF Completion Guidelines, and Data Review GuidelinesOversee user acceptance testing (UAT) of eCRFs and associated edit checksConduct data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholdersReview and monitor data quality metrics to ensure clean, consistent, and analyzable datasetsCollaborate with CROs to manage timelines and deliverables for data management activitiesContribute to database lock activities, ensuring audit readiness and data integrityMaintain and QC study-specific trackers and metrics dashboardsCreate and manage data deliverable timelines and tasksReview and provide feedback on vendor data transfer agreements, transfers and reconciliationProvide support to the Clinical Data Management Lead on study-related tasks and initiativesThe Ideal Candidate will have:BS with 8+ years or MS with 5+ years of clinical data management experience in CRO, pharma, or biotech settingsStrong experience with Medidata Rave EDC systems and electronic trial master files (eTMF)Demonstrated knowledge of ICH/GCP, FDA regulations, and clinical trial processesProficiency in industry data standards including CDISC, SDTM, and CDASHPrior experience collaborating with CROs on clinical studiesHighly organized with excellent communication and interpersonal skillsExperience in small biotech environments highly preferredNice to Have (Optional):Experience supporting IND or BLA submissionsFamiliarity with data visualization or analytics toolsExposure to AI-enabled or digital trial approachesWhy Join Us:At Generate : Biomedicines , we are pioneering generative biology to create novel therapeutics that could transform patient lives. You will join a mission-driven team that values collaboration, innovation, and continuous growth. As part of our Clinical Development organization, you will help build scalable, digital-forward data practices in a company poised to redefine what’s possible in biomedicine.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. Recruitment & Staffing Agencies : Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.Per Year Salary Range$140,000 — $196,000 USD