Company Overview

This pharmaceutical organization develops therapies to tackle cancer and other serious diseases.

Title: Clinical Operations Senior Operations Manager — JO-2202-5734

Territory: Various

Therapeutic Area: Oncology

The Senior Operations Manager collaborates with the Director of Clinical Operations to (1) oversee the execution of studies, on schedule and on budget, in assigned clinical program(s) in compliance with quality standards, (2) oversee CROs and other third-party vendors to meet the Company’s obligations described in ICH-GCP and the Company’s objectives. 

Reports to the Director of Clinical Operations.

Essential Duties and Responsibilities

  • Provide subject matter expertise and operational input into study-related documents, including but not limited to the clinical study protocol, pharmacy manual, monitoring plan, protocol deviation plan, and the communication plan to ensure compliance with the Company’s SOPs as required.
  • Assist Clinical Project Managers in the development and maintenance of study management plans and budgets.
  • Oversee CRO/vendor selection, budget and contract negotiation, and performance for all activities assigned to a CRO/vendor, including escalation of issues to Direction of Clinical Operations and Quality Assurance team when required.
  • Mentor/coach Clinical Project Managers and CRAs as needed to ensure trial success. This may involve attending internal and external project meetings and co-monitoring visits with site CRAs.
  • Assist with the onboarding of new clinical team members.
  • Review and collate clinical team metrics, as directed, for review and discussion with senior management.
  • Support Director of Clinical Operations with the management of the clinical budget as required.
  • Work closely with the Quality assurance team on the audit plan and oversee CAPAs following vendors/site/company audits.
  • Support the Director of Clinical Operations in the development and maintenance of clinical SOPs and trial process.
  • Act as a line manager if required.
  • Build a positive culture within clinical operations and cross-functionally.

Qualifications (Education & Experience)

  • Degree in scientific or healthcare discipline.
  • Ideally 7-plus years of pharmaceutical industry experience with 5 years of strong clinical research experience.
  • Experience in a monitor role or a role overseeing clinical trials.
  • Strong project management skills.
  • Excellent verbal and written communication skills.
  • Highly proficient negotiation skills.
  • Ability to work under pressure.

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.

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