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

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