Clinical Program Manager/Sr. Clinical Program Manager

Location
Remote or Hayward , California
Posted
Apr 16, 2021
Ref
216
Required Education
Bachelors Degree
Position Type
Full time

About us:

 

Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.


We are located in the San Francisco bay area, in the heart of the world’s largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.


Job Summary:

 

In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.   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.  This position is remote or in-house, depending on prior experience.  Any in-house positions for this role will begin home-based until offices are opened to normal operating procedures.


Job Responsibilities:

 

Responsibilities may include, but are not limited to:

 

  • 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)