Clinical Program Manager

Job Title: Clinical Program Manager

Job Number: 89194

Location: Remote, US

Job Description

The Clinical Program Manager 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.  

Responsibilities

Lead cross-functional study management teams to ensure effective planning, implementation, and execution of Phase I-IV clinical trials, managing timelines, resources, and budgets. Oversee operational activities from study start-up to close-out and serve as the primary contact for functional teams and vendors involved in protocol execution. Supervise internal clinical operations, CROs, and other service providers associated with assigned studies. Contribute to the development and review of key study documents, including Investigator Brochures, study protocols, informed consent forms, and study materials. Establish study milestones, track progress, prepare budgets, and ensure adherence to ICH GCP, regulatory standards, protocol requirements, and company SOPs. Conduct site visits for evaluation and monitoring as needed, participate in Quality Assurance audits, and support the outsourcing and selection of service providers. Coordinate and lead Investigator Meetings and provide study-specific training to CROs, monitors, and sites. Implement strategies to enhance efficiency and quality in study management, while mentoring junior team members.

Required Skills

* Education: Bachelor’s degree, preferably in a scientific field. * Experience: 7+ years in the pharmaceutical industry or equivalent, with 5+ years in study management at a Sponsor or CRO; recent oncology experience required. * Expertise: In-depth knowledge of ICH GCP guidelines and advanced clinical research concepts, with hands-on experience in study execution from start-up to closure (e.g., data management, safety, biostatistics, medical writing). * Skills: Strong interpersonal, negotiation, and communication skills, including presenting to internal teams and external partners. Effective at selecting and managing investigative sites, CROs, and vendors. * Attributes: Self-motivated, assertive, able to work both independently and collaboratively as part of a team.Salary 145-165k/yr

Application Deadline: 2024-12-30