Clinical Program Manager

Location
94545, Hayward
Salary
TBD
Posted
Oct 24, 2018
Ref
CD-PPM
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.  

Overall Description: 

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. 

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)

Qualifications:

  • 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 
  • 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
  • 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)