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Clinical Program Manager, Oncology, Contractor (Office or Remote)

Posted 12 weeks ago
Project Management
Full Time
United States

Overview

The Clinical Program Manager (CPM) is accountable for leading day-to-day operations of one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. This role is responsible for working with and leading selected vendors in the execution of the clinical trials assigned. This position will report to a Clinical Program Director.

In Short

  • Lead cross functional study management team to ensure effective planning, implementation and execution of clinical trials within agreed timelines, resources and budget
  • Facilitate operational activities pertaining to the execution of Ph I-IV clinical trials from study start through close-out
  • Primary contact for functional area representatives and vendors responsible for protocol execution
  • Provide oversight of internal clinical operations team members, CROs, service providers and consultants that are involved in assigned studies
  • May assist in the development and review of Investigator Brochure, study protocols, case report forms, and clinical study reports
  • Development and review of informed consent forms, study plans, study materials and tools
  • Establishes study milestones and ensures accurate tracking and reporting of study progress
  • Preparation of study budgets and timelines
  • Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs
  • May conduct site visits for oversight, site evaluation, initiation, monitoring, or close-out activities
  • Participate and respond to Quality Assurance and regulatory authority inspection audits
  • Participating in service provider selection process as a part of outsourcing activities
  • Responsible for selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
  • Plan and coordinate Investigator Meetings
  • Recommends and implements innovative ideas to increase efficiency and quality of study management activities
  • Mentoring junior team members

Requirements

  • Bachelor’s degree, preferably in a scientific field
  • Minimum of 7+ years of related industry experience in the pharmaceutical industry or equivalent, with 5+ years of study management experience at a Sponsor or CRO, recent oncology experience required
  • Proven ability to lead a study team
  • Excellent communication skills both verbal and written are required
  • Flexibility and willingness to step in and be a team player
  • Strong problem-solving skills with the ability to focus on time-sensitive objectives.

Benefits

  • Equal Opportunity Employer
  • Commitment to diversity and inclusion

A.B

Arcus Biosciences

Arcus Biosciences is a biotechnology company focused on developing innovative cancer therapies, particularly in the field of oncology and immunotherapy. The company emphasizes a collaborative and cross-functional approach to clinical development, aiming to drive the design, planning, and implementation of clinical trials for investigational products. With a commitment to scientific excellence and regulatory compliance, Arcus Biosciences fosters an inclusive work environment that values diversity and equal opportunity for all employees.

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