Clinical Trial Operations Manager

4 days ago

California, United States Hamlyn Williams Full time
About the Role

Hamlyn Williams is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will play a critical role in the development and commercialization of innovative biotherapeutics.

Key Responsibilities
  • Study Management: Support and coordinate clinical trial activities, manage execution of 1 or more clinical trials/programs to ensure completion according to timelines.
  • Vendor Management: Manage overall study timelines and oversight of the vendors' deliverables, including CROs and third-party vendors.
  • Study Design and Development: Assist and contribute to the design of study materials, such as IND submission documents, protocols/amendments, ICFs, patient diaries, and other study-related materials.
  • Study Planning and Coordination: Prepare, assist, and develop study plans, including monitoring manuals, study operations manuals, source data verification plans, pharmacy manuals, and laboratory manuals.
  • Study Supplies Coordination: Coordinate study supplies.
  • Project Management: 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).
  • Regulatory Compliance: Develop and review SOPs and processes, guidelines for compliance with global regulatory requirements.
  • Team Leadership: Provide supervision, coach, and mentoring, and contribute to hiring new staff.
  • Risk Management: Proactively identify risks, develop, and implement mitigation strategies.
Requirements
  • Education: BS/BA or equivalent degree.
  • Experience: Ideal candidate will have at least 5 years of relevant experience in either sponsor or CRO (at least 2 years clinical trial management experience).
  • Clinical Trial Experience: At least 1 year of clinical trial experience in oncology required.
  • Track Record: Strong track record for successful study initiation and execution.
  • Leadership Experience: Experience leading clinical trials preferred.
  • Regulatory Knowledge: Working knowledge of policies and procedures that govern clinical research, including but not limited to FDA regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA).
  • Vendor Management Experience: Experience managing CROs and third-party vendors.
  • Financial Management Experience: Experience in Finance Management (Budget forecasting, review of SOW, invoices, and accruals).
  • Technical Skills: Experience working with EDC, CTMS, and eTMF systems.
Skills and Abilities
  • Self-Motivation: Self-motivated and able to thrive in a fast-paced, start-up environment.
  • Communication Skills: Skilled in communicating effectively, both written and verbal.
  • Leadership Skills: Must have exceptional leadership skills, including motivation and delegation.
  • Relationship Building: Ability to establish and maintain effective and productive working relationships with all employees, in a variety of organizations.
  • Customer Service: Exceptional customer service and people skills.
  • Attention to Detail: Attention to detail.

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