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Associate Director Clinical Operations

Associate Director Clinical Operations

ActalentCambridge, MA, US
Hace 12 horas
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Associate Director, Clinical Operations

Manage clinical trial activities for multiple trials, ensuring the timely completion of deliverables through development, management, and oversight of the trial CROs, timeline, and budget. This role involves partnering with Clinical Development and other functions to develop operationally feasible and clear protocol concepts and final protocols. The candidate must be comfortable independently leading internal study teams, as well as managing outsourced activities and responsibilities delegated to CROs and / or other service providers.

Responsibilities

  • Manage clinical trial activities for multiple trials, ensuring timely completion of deliverables.
  • Develop, manage, and oversee trial CROs, timeline, and budget.
  • Partner with Clinical Development and other functions to develop operationally feasible and clear protocol concepts and final protocols.
  • Lead internal study teams independently.
  • Manage outsourced activities and responsibilities delegated to CROs and / or other service providers.
  • Contribute to biostatistics, medical writing, safety, regulatory affairs, and quality assurance activities.
  • Interact closely with investigators and site staff through routine calls and site sponsor visits.

Essential Skills

  • Minimum BA / BS degree.
  • Minimum 8 years of clinical research / trial management experience.
  • Demonstrated knowledge and understanding of FDA / EMA / GCP / ICH regulations and guidelines.
  • Ability to provide appropriate leadership to clinical sites.
  • Strong problem-solving capability.
  • Global experience required.
  • Strong vendor / CRO management experience.
  • Must be willing to travel, both domestic and international.

    • Additional Skills & Qualifications

  • Open to a tenured Sr. CTM ready to take the next step into an AD role or someone coming from an AD position.
  • Gene therapy experience would be a nice to have.
  • Experience with submissions and inspections.
  • Small biotech experience strongly preferred.
  • Experience in gene therapy and neuromuscular fields preferred.

    • Pay and Benefits

    The pay range for this position is $155000.00 - $215000.00 / yr. Health insurance, PTO, 401K, sick time, etc.

    Workplace Type

    This is a fully remote position.

    Application Deadline

    This position is anticipated to close on Oct 17, 2025.

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    Associate Director Clinical • Cambridge, MA, US