Nexagen Search is hiring a Clinical Program Manager (remote) for a mid-sized, oncology focused biotechnology company. Nexagen Search is a life sciences focused recruitment firm and represents organizations in the biotechnology and pharmaceutical industries. To learn more about our company, please visit our website: www.nexagenhr.com

Summary:

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.

Compensation: The expected base compensation for this position is $140,000 - $165,000 per year, plus annual bonus, stock package, and benefits.