Specialist II, Translational Development Operations (Biospecimen) - San Francisco, CA | Biospace
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Specialist II, Translational Development Operations (Biospecimen)

Celgene

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Location:
San Francisco, CA
Posted Date:
5/28/2017
Position Type:
Full time
Job Code:
17000063
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description


Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.


Summary/Scope

The Specialist II is expected to execute on Translational Development Operations (TDOps) service deliverables under minimal supervision in a fast-moving team-based environment.  The incumbent will provide biomarker specimen 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 TDOps 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 TDOps 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.TD Operations: 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 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 timeframes.  

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 sample 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.


*LI-MG2

BIO-US

Requirements

Qualifications

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 4+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment






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.

  • Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.
  • 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.
  • Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements.
  • 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.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.


Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.