Clinical Trial Manager

2 months ago

Mountain View, United States IGM Biosciences, Inc. Full time

Position Summary

We are seeking an experienced Clinical Trial Manager to successfully manage and execute one or more oncology first in human phase I, II, and III global clinical trials. The ideal candidate must be able to manage all clinical and operational aspects of one or more clinical trials with minimal supervision. Experience in all phases of clinical trial management is preferred, including study start-up activities, patient enrollment initiatives, study maintenance, and close-out. Must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, and developing SOPs.


This hybrid role requires one to be onsite to collaborate with partners and key stakeholders in Mountain View, CA, a minimum of 3 days per week.


Exemplary communication skills in all forms in a cross-functional collaborative manner are required.


Responsibilities:

  • Provide leadership and oversight in all aspects of clinical operations from planning and executing 1 or more complex oncology clinical trials (site selection, start-up, enrollment, maintenance, and close-out).
  • Responsible for oversight and project management of individual studies as well as relevant program-related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up).
  • Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget.
  • Participate in the selection of CRO and vendors, including the development of RFPs, budget negotiations, and management.
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines and critical study activities.
  • Develop and maintain enrollment and budget forecast.
  • Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings.
  • Develop study plans, including vendor oversight, risk, safety, and communication plans.
  • Proactively identify risks, develop and implement mitigation strategies.
  • Self-motivated and able to thrive in a fast-paced, start-up environment.
  • Support development of new SOPs and processes.
  • Provide supervision, coach, and mentoring of early career colleagues, and contribute to hiring new staff.
  • Able to travel (~20%)


Requirements:

  • Level commensurate with experience.
  • This hybrid role requires one to be onsite in Mountain View, CA, a minimum of 3 days per week.
  • Minimum 8 years of relevant clinical operations experience at either sponsor or CRO companies, or a minimum of 6 years clinical trial management experience in Oncology with a MS degree or higher.
  • Bachelor’s degree or equivalent is required.
  • Strong track record for successful study initiation and execution.
  • Assertive driver of project deliverables.
  • Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations.
  • Relevant oncology therapeutic areas and Phase I, II and III experience strongly preferred.
  • Experience managing CROs and third-party vendors.
  • Experience in Finance Management (Budget Forecasting, Change Order management, etc.).
  • Experience working with EDC, CTMS, and eTMF systems.
  • Strong interpersonal communication skills.
  • Excellent cross-functional clinical project management skills.
  • Must have exceptional leadership skills, including motivation and delegation.

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