What are the responsibilities and job description for the Clinical Program Director, Oncology position at Arcus Biosciences?
Overview
Arcus Biosciences seeks an experienced Clinical Program Manager, responsible for leading day-to-day operations of clinical studies. This role ensures efficient delivery of clinical trials in a matrix environment by working with and leading selected vendors.
Responsibilities
• Lead cross-functional study management teams to ensure effective planning, implementation, and execution of clinical trials within agreed timelines, resources, and budget requirements.
• Facilitate operational activities pertaining to the execution of Phase I-IV clinical trials from study start through close-out.
• Provide primary contact for functional area representatives and vendors responsible for protocol execution.
• Oversee internal clinical operations team members, CROs, service providers, and consultants involved in assigned studies.
• Assist in the development and review of Investigator Brochures, study protocols, case report forms, and clinical study reports.
• Develop and review informed consent forms, study plans, study materials, and tools.
• Establish study milestones and ensure accurate tracking and reporting of study progress.
• Prepare study budgets and timelines.
• Ensure studies are managed and executed in accordance with ICH GCP guidelines, regulations, the protocol, and company SOPs.
Qualifications
• 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.
• Flexibility and willingness to step in and be a team player.
• Strong problem-solving skills with the ability to focus on time-sensitive objectives.
Arcus Biosciences seeks an experienced Clinical Program Manager, responsible for leading day-to-day operations of clinical studies. This role ensures efficient delivery of clinical trials in a matrix environment by working with and leading selected vendors.
Responsibilities
• Lead cross-functional study management teams to ensure effective planning, implementation, and execution of clinical trials within agreed timelines, resources, and budget requirements.
• Facilitate operational activities pertaining to the execution of Phase I-IV clinical trials from study start through close-out.
• Provide primary contact for functional area representatives and vendors responsible for protocol execution.
• Oversee internal clinical operations team members, CROs, service providers, and consultants involved in assigned studies.
• Assist in the development and review of Investigator Brochures, study protocols, case report forms, and clinical study reports.
• Develop and review informed consent forms, study plans, study materials, and tools.
• Establish study milestones and ensure accurate tracking and reporting of study progress.
• Prepare study budgets and timelines.
• Ensure studies are managed and executed in accordance with ICH GCP guidelines, regulations, the protocol, and company SOPs.
Qualifications
• 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.
• Flexibility and willingness to step in and be a team player.
• Strong problem-solving skills with the ability to focus on time-sensitive objectives.
