Clinical Trial Sample Management Associate

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:

The clinical operations department is a central, vital element of our medicine development program at Arcus. In 2020 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 Responsibilities:

• Assist the sample management lead in the review of laboratory “scopes of work”, manuals and training materials; participate in 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, report on critical metrics 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
• 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

Qualifications (including knowledge & skills):

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 working with 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
• Advanced Microsoft Excel skills a plus
• Effective verbal and written communication (including presentation of ideas/materials to internal teams and external partners)
• Proven problem solving and decision-making skills