Clinical Program Manager/Sr. Clinical Program Manager (CPM)

Location
Hayward, California
Posted
Jun 09, 2021
Ref
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Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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.

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)

Arcus Biosciences is an equal opportunity employer.