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Biosample Operations Manager II
Ref No.: 20-02544
Location: South San Francisco, California
Biosample Operations Manager II
Contract: 06/01/2020-06/01/2021
Location: South San Francisco, CA

Join a global biopharmaceutical company committed to healthcare solutions from prevention to treatment. We turn scientific discoveries into medicine to improve human health. Every day we dedicate out most important resource, our people, to support patients and families through their health journey.
 
Duties:
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Partners with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, kit contents, shipping conditions and logistics for biomarker samples
  • Performs ongoing biomarker vendor management including development and oversight of scope of work, budgets (invoice review & reconciliation) and performance management
  • Serves as primary point of contact for laboratories performing biomarker analysis and hence supports the biomarker outsourcing process through effective vendor management
  • Identifies areas of best practice and process improvements
  • Participates in Product Development Global Operations initiatives and programs as assigned
  • May lead or be a representative on functional groups goals, initiatives and work-streams
  • Ensures study adherence to ICH/GCP and SOPs
  • in some cases, may also be applicable to bioanalytical samples in partnership with the bioanalytical managers
Skills:
● Extensive clinical development experience with evidence of working in teams running clinical studies
● Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
● Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
● Project management skills
● Critical reasoning skills including the identification and resolution of complex problems
● Detail oriented with the ability to work independently and manage multiple competing priorities
● Planning, organizational and time management skills
● Highly flexible in a fast pace global matrix environment
● Professional interpersonal skills, excellent oral/written communication and influencing skills
● Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
● Creates team culture and promotes team spirit.
● Global Vendor Management experience preferred
● Good knowledge of ICH GCP
Competencies
Strategic Agility
Inspiring and Influencing
Teamwork and Collaboration
Communication
Technical and Business Expertise
Achieving Results

Education:
● Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
● 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment