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Senior Clinical Trial Manager, Cambridge, MA

Isomorphic Labs· Clinical
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Cambridge, MAPosted 2mo ago

About the role

Senior Clinical Trial Manager role in Cambridge, MA at Isomorphic Labs, leading cross-functional teams through the full clinical trial life cycle in alignment with ICH/GCP guidelines, with potential program and managerial responsibilities as the department grows.

Responsibilities

  • Execute/manage all study start-up, maintenance and close-out activities.
  • Demonstrate AI-curious mindset to explore and leverage emerging AI technologies for streamlined contract lifecycle management and operational efficiency.
  • strategically analyze and problem-solve in fast-paced, matrixed environments; build cross-functional relationships, mentor team members, and drive solutions across boundaries.
  • Manage Change Orders and re-scoping with vendors/sites, verify invoice accuracy and service costs vs accruals.
  • Contribute to writing of clinical documents (Protocol, ICF, DSUR, IB, CSR) for timely submission readiness.
  • Create and update trial plans to keep them current.
  • Develop or oversee training and day-to-day materials (SIV, amendment training, lab/pharmacy manuals, etc.).
  • Support data management activities (study manual, edit check manual, clean patient data tracker, listings, SAS/SAF planning).
  • Participate in data cleaning and plan data snapshots for reviews and data deliveries.
  • Monitor vendor metrics and performance (KPIs, monitoring reports, deviations, data cleaning, enrollment).
  • Identify and assess AI solutions that could be helpful to the organization.
  • Coordinate and participate in all study-related meetings ( Investigator teleconferences, study team meetings, vendor calls, safety meetings, DSMB, etc.).
  • Assist CRO in eTMF development and maintenance to ensure audit-ready TMF at study end.
  • Support audit, SOP and quality activities to ensure operational excellence.

Qualifications

  • Bachelor's Degree in a related field
  • minimum 6 years experience in biotech/pharmaceuticals
  • At least 3+ years managing oncology or rare disease trials
  • Thorough understanding of GCP/ICH guidelines and cross-functional clinical processes
  • Excellent interpersonal and communication skills
  • Proactive problem solving, planning and project management skills
  • Strong outsourced model experience with vendor budget management
  • Ability and willingness to travel up to 30%

Skills

Required:Clinical trial managementGCP/ICH knowledgeVendor managementCross-functional collaboration
Nice to have:Data management support
Last updated Aug 26, 2026. Interested? Apply on the company site.

About Isomorphic Labs

Reimagining Drug Discovery Process with AI

Isomorphic Labs is building a future where frontier AI can help to unlock deeper scientific insights, faster breakthroughs, and life-changing medicines.

AIBiotechnologyDrug DiscoveryPharmaceuticalsliquid-ai-recruiting-target
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