Clincal Trials Sample Management Associate

Location
94545, Hayward
Salary
TBD
Posted
Jul 24, 2019
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

The clinical operations department is a central, vital element of our medicine development program at Arcus. In 2019 we are expanding the scope and size of this team, with positions available immediately for self-motivated, collaborative individuals.

We are currently seeking a clinical trial sample management associate who will coordinate the vital process of managing and transferring samples from our clinical trial sites to specialist researchers responsible for assessing the effects of our novel drugs and drug combinations. This is a rare opportunity to further a career in the exciting field of clinical operations as a core member of our world‑class team. The successful applicant will win the opportunity to work independently and collaboratively across all Ph I-IV studies/programs within our clinical portfolio, contributing meaningfully to the development of tomorrow’s medicines from our headquarters at Hayward in the SF Bay Area.

Job Duties and Responsibilities: 

  • Developing/reviewing laboratory “scopes of work”, manuals and training materials; responsibility for delivering training to internal staff or external partners (e.g., CRO, investigator site staff) as required
  • Collaborating with cross-function study management teams to ensure delivery of sample data per project milestones
  • Assisting in the development of laboratory materials, clinical study kit design and laboratory manuals
  • Working closely with internal and external groups/vendors to provide oversight of clinical sample collection and to identify and resolve sample-related issues
  • Managing and coordinating the acquisition of clinical trial samples designated for analysis
  • Maintaining accurate internal/external sample databases
  • Organizing and managing internal team meetings related to the management of samples and vendor management, as requested
  • Laboratory oversight and governance/relationship management activities
  • Participating in internal/external audits and respond to audit findings, as requested
  • Recommending and implementing innovative ideas to increase efficiency and quality of sample-related activities including establishing internal process and systems to support sample management
  • Reviewing study plans, informed consent forms, operational manuals, or other trial level documents as relates to sample management, as requested

Qualifications:

  • Bachelor’s degree, preferably in a scientific field
  • A minimum of 2 years relevant clinical trial experience in the pharmaceutical or health care sectors or equivalent academic setting
  • Thorough knowledge of ICH GCP and GLP guidelines
  • Detailed understanding of clinical trial processes from study start-up through study closure
  • Prior laboratory or other sample handling experience strongly preferred
  • Previous experience establishing a sample management system would be a distinct advantage

Skills/Abilities:

  • Demonstrated ability to establish priorities, work with a strong sense of urgency and collaborate (interpersonal, relationship management) effectively with the study team, cross functional team members and external partners/vendors
  • Self-motivated, assertive and able to function both independently and as part of a geographically distributed team
  • Strong interpersonal and negotiation skills
  • Effective verbal and written communication (including presentation of ideas/materials to internal teams and external partners)
  • Proven problem solving and decision-making skills