Specialist II Biospecimen Operations

Req #: 1804048
Location: San Francisco, California, United States
Job Category: Research and Early Development
Work Location: 1500 Owens Street 94158
Organization: Translational Medicine
Employee Status: Full-time
Job Type: Regular
Other Locations: United States-New Jersey-Summit, United States-Washington-Seattle

****This position can be located in San Francisco, CA; Seattle, WA or Summit, NJ****

PREREQUISITES

Bachelors Degree in a life sciences or healthcare related field with 6+ years related
professional experience in an academic clinical research setting,
clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
OR
Masters Degree in a life sciences or healthcare related field and 5+ years related
professional experience in an academic clinical research setting,
clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Summary/Scope

The Specialist II is expected to execute on Biospecimen Operations (BSO) service deliverables under minimal
supervision in a fast-moving team-based environment. The incumbent will provide biospecimen and clinical
trial support across multiple, often complex, studies in oncology and inflammation/immunology. He/She is
expected to serve as the lead trainer on biospecimen logistics and represent BSO at national/international
clinical site initiations and investigator meetings. The Specialist II is viewed as a mentor to peers and is
expected to assist them with issue analysis and solutions. The ideal candidate is a team-player who is detail oriented;
is able to successfully multi-task, supporting several projects simultaneously; understands the
broader context of support that he/she provides; and knows how to identify/recognize and resolve issues with
minimal supervision.

Responsibilities will include, but are not limited to, the following:

The Specialist II will be expected to drive internal and external work group results to support the department's
mission. In doing so, the incumbent is expected to stay current on the broader context of support that he/she
provides, assess quality support from the process improvement perspective, identify gaps and needs, propose and
drive solutions, He/She will also be expected to escalate/resolve issues, lead/facilitate effective meetings and
manage conflict with minimal guidance. The primary responsibilities of the BSO Specialist II are to support TD
and clinical teams in the implementation and maintenance of biospecimen management strategies for often
complex, global clinical studies in each of the following areas under minimal supervision:

1. BSO: Maintain knowledge/status of assigned clinical protocols and be able to follow good clinical
practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Might be
called upon to assist in the authorship of SOPs and WPs. Be able to handle, identify and resolve
complex biospecimen-related/site issues and implement viable solutions in a timely manner. Play a
key role in planning and designing clinical trial and biospecimen operations support internally and
externally.

2. Biospecimen management: Utilize software tools such as Labmatrix to track biospecimens, identify
discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by
following written procedures. Maintain regular metrics of biospecimen activities for studies that
he/she supports. Follow up and resolve discrepancies through communication with study team, sites,
or CROs/vendors within specified time frames.

3. Clinical study teams: Plan/design biospecimen handling logistics and review biomarker-related
clinical documents clinical protocols, ICFs, CRFs for successful study start-up. Create and maintain
biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical
sites. Support clinical and/or CRO to review supporting biospecimen documentation, labels,
requisition forms and manifests to ensure documented biospecimen chain-of-custody and the rapid
reconciliation of biospecimens.

4. CROs and Vendors: Work with manager and clinical development teams to plan/design biospecimen
handling logistics with preferred vendors on the manufacture of sample collection kits and execution
of associated logistics; will be expected to take on a primary role in working with scientists and
analytical laboratories on generating work order requests, work specifications and logistics.

Skills/Knowledge Required:

The incumbent should have proficient skills in each of the following areas and have demonstrated application in
the context of clinical trials and biospecimen management.

• Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated,
intuitive understanding of clinical trials.
• Scientific/Laboratory Skills: Proficient knowledge of relevant therapeutic and technical areas;
demonstrated understanding of laboratory techniques in the life sciences; demonstrated understanding of
principles in clinical research and clinical procedures involving blood/biopsy collection, handling and
processing.
• Biobanking: Understanding of global biobanking issues; proficient experience working in organizations
adhering to quality standards and working with regulations pertaining to general biospecimen
transportation requirements.
• Drug Development: Proficient understanding of the drug development process.
• Professional inter-personal skills and excellent oral/written communication. Experienced in presenting
logistics and processing instructions, including basic scientific and clinical content, to internal and
external audiences.
• Basic leadership skills in conflict management, facilitation and negotiation.
• Proficient computer skills in Microsoft Office.
• Experience with databases and intermediate-level Excel a plus.
• Up to 20% travel to clinical sites to train sites on biospecimen procedures.

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About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.