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Senior Director Clinical Operations

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  • Location: New Jersey
  • Salary: $200,000 - 280,000

Posted etwa 7 Stunden her

  • Contact: Hannah Wyllie
  • Contact Phone: (929)242-9767
  • Start Date: ASAP
  • Expiry Date: 01 April 2023

Senior Director Clinical Operations

Hybrid

$200,000 - $280,000 Annual Salary Based on Experience + Competitive Bonus

Position Overview:

The Senior Director Clinical Operations will be responsible for managing all operational functions of clinical trials & study management at an impressive Biotech. Oversight of trials & CRO work with adherence to GCP & ICH guidelines, ensuring inecption readiness. They will be an experienced Clinical Operations leader who is eager & motivated to be part of the team advancing care forward.

Responsibilities include but are not limited to:

  • Responsible for the management of all clinical operations & study activities & personnel following them. From compliance to adherence of deadlines.

  • Vendor management & oversight for all studies managed by the vendor.

  • Establish and drive a team of internal and external multi-functional stakeholders ; evaluate and develop ideal outsourcing model for delivery on clinical portfolio, including oversight of CROs and other vendors/external partners.

  • Represent Clinical Operations group at cross functional meetings.

  • Provide input for any clinical audits & inspections alongside quality team.

  • Authoring & revising SOPs.

  • Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan).

  • Providing needed training to ensure deliverables are properly met.

  • Ensures comprehensive operational input to Clinical Strategy with other stakeholders.

Minimum Requirements:

  • BS/BA degree or equivalent in health related field. *An advanced degree is preferred.

  • 8+ Years in the Clinical Operations space within Biotech/Pharma industry.

  • Leadership experience managing clinical trials.

  • Strong understanding of ICH, GCP, and relevant regulatory requirements

  • Global clinical trial conduct and clinical operations experience, from start-up to database lock. A thorough understanding of the processes associated with project and study management.

  • Leadership skills & innovative mindset.