In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.
The Project/Program Manager (PM) is accountable for leading day-to-day operations of one or more clinical studies/programs, ensuring efficient delivery of clinical trials in a matrix environment. This activity is typically coordinated in conjunction with one or more CROs. This position will report to either the Associate Director/Director in Clinical Operations or Head of Clinical Development. Project management in areas outside of therapeutic clinical trials DOES NOT count as relevant experience for this role.
Job Duties and Responsibilities:
Responsibilities may include, but are not limited to:
Lead Clinical Trial Team meetings
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 CROs, service providers and consultants that are involved in assigned studies
May assist in the development and review of Investigator Brochure, study protocols, informed consent forms, case report forms, study plans, clinical study reports, study materials and tools
Establishes study milestones and ensures accurate tracking and reporting of study progress
Prepares study budgets and timelines
Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol and company SOPs
May visit sites (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
Responsible for and participates 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 project/program management activities
This position will report to either the Associate Director/Director in Clinical Operations or Head of Clinical Development (dependent on experience or seniority)
Bachelor’s degree, preferably in a scientific field
A minimum of 5 years of Clinical Trial management experience at a Sponsor or CRO, preferably in Oncology. Project management in areas outside of therapeutic clinical trials DOES NOT count towards this minimum.
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.
Thorough understanding of ICH GCP guidelines
Understanding of clinical trial processes 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 or 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
May have line management responsibilities
Ability and willingness to travel 10-20% (domestic and international)
Internal Number: CD-PPM
About Arcus Biosciences
Arcus is utilizing its small molecule discovery and development capabilities to create innovative cancer immunotherapies.