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.
Responsibilities:
- 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 (in conjunction with CRO, if applicable) 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.
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 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.
Skills/Abilities:
- Thorough understanding of ICH GCP guidelines.
- Familiar with advanced concepts of clinical research and experience in driving execution, from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing).
- Self-motivated, assertive, and able to function independently and as part of a team.
- Effective in selection of investigative sites, CROs, and vendors and management of external resources.
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners).
- Proven problem solving and decision-making skills.
- Excellent planning and organization skills.
- May have line management responsibilities.
- Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.).
- Ability and willingness to travel 10-20% (domestic and international).
This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $145-164,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package.
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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