Senior Clinical Trial Manager, Cambridge, MA

Isomorphic Labs
Cambridge
Workplace: HybridFull timeFunction: Solutions Engineering & Sales EngineeringExperience: 6+ yearsEducation: bachelorsSkills: ["Interpersonal communication","Cross-functional collaboration","Problem-solving","Planning","Adaptability"]

Independently lead cross-functional clinical trial activities across the full life cycle, from study start-up through conduct and close-out, aligned to ICH/GCP and industry/corporate standards. Own trial planning and updates, manage change orders with vendors and sites, and oversee clinical documentation (protocol, ICF, DSUR, IB, CSR) for submission readiness. Coordinate study meetings, support eTMF/TMF readiness, and partner with data management and vendors to ensure quality, compliance, and operational efficiency.

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FursaFursa
Isomorphic Labs
Isomorphic Labs
2 days ago

Senior Clinical Trial Manager, Cambridge, MA

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Last checked: 2 minutes agoStatus: Live

Job Summary

Independently lead cross-functional clinical trial activities across the full life cycle, from study start-up through conduct and close-out, aligned to ICH/GCP and industry/corporate standards. Own trial planning and updates, manage change orders with vendors and sites, and oversee clinical documentation (protocol, ICF, DSUR, IB, CSR) for submission readiness. Coordinate study meetings, support eTMF/TMF readiness, and partner with data management and vendors to ensure quality, compliance, and operational efficiency.
Location: Cambridge
Workplace: Hybrid
Employment Type: Full time
Job Function: Solutions Engineering & Sales Engineering
Seniority: Manager level

Key Responsibilities

  • •Independently lead a cross-functional team through all clinical trial life-cycle activities, aligned to ICH/GCP and applicable standards.
  • •Execute/manage study start-up, maintenance, and close-out activities, including trial plan creation and updates.
  • •Drive, contribute to, and support writing clinical documents (Protocol, ICF, DSUR, IB, CSR) for timely and accurate submission readiness.
  • •Manage change orders and re-scoping with vendors and sites, including invoice accuracy and cost-of-services vs. accruals.
  • •Coordinate study-related meetings and support audit/SOP/quality activities, including CRO support for eTMF development and audit-ready TMF close-out.
Travel: Medium travel

Key Requirements

  • •Bachelor's degree in a related field and minimum 6 years of experience in the biotech and/or pharmaceutical industries.
  • •At least 3+ years managing oncology or rare disease trials.
  • •Thorough understanding of GCP/ICH guidelines and strong understanding of cross-functional clinical processes.
  • •Excellent interpersonal and communication skills for cross-functional relationship building.
  • •Proactive problem-solving, planning, and project management skills, including strong outsourced-model/vendor budget experience.
Experience:6+ yearsBiotechPharmaceuticalsOncologyRare disease
Education:Bachelor's
Skills:Interpersonal communicationCross-functional collaborationProblem-solvingPlanningAdaptability
Languages:English
Tech Stack:GCP/ICHETMFTMF

Company Brief

Isomorphic Labs
Uses machine learning and computational biology to accelerate drug discovery and design novel therapeutics by modeling protein structures, mechanisms, and interactions to identify promising targets and candidates.
Industry: Biotech
Company Size: Medium (51 to 250 employees)
Growth: Growth Stage Startup
Headquarters: London, United Kingdom
Founded: 2021
WebsiteLinkedIn