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Senior Clinical Trial Manager / Clinical Trial Manager
Confirmed live in the last 24 hours
Belmont, MA, USA
Experience Level
Desired Skills
Google Cloud Platform
  • Bachelor's degree in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field
  • 4+ years as a project/clinical trial manager, biotechnology experience is highly desirable
  • Experienced in managing early development phase clinical trials, immuno-oncology trials experience preferred
  • Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects
  • Management of overall project timeline
  • Strong leadership skills
  • Manages all clinical aspects of study including:
  • Uses operational and therapeutic expertise to optimize trial design and execution
  • Typically works with the department leadership to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment
  • Proactively identifies and resolves clinical project issues
  • Responsible for selection, qualification, and management of vendors to support clinical trial execution
  • Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables
  • Provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel
  • Plans, executes, and leads study-specific meetings (e.g., internal core team meetings, investigator meetings, Advisory Committee)
  • Participates in site monitoring visits as appropriate
  • Provides input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc
  • Reviews monitoring reports to ensure quality and resolution of site-related issues
  • Ensures tracking and review of protocol deviations and assesses impact on study data
  • Develops relationships with investigators and site staff; critical to be comfortable engaging KOLs in scientific discussion
  • Proactively review individual data points and data listings to identify signals or trends
  • Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review
  • Working closely with translational medicine team, ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review
  • Preparing data summaries and presenting to internal and external stakeholders
Kymera Therapeutics

51-200 employees