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Clinical Biosample Operations Manager

Kelly Services

Redwood City, CA
Job Code:
  • Healthcare
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Job Details

Job Title Clinical Biosample Operations Manager

Jobid US15TPCT_BH1398258

Location: Redwood City, CA, 94061, USA

Description Kelly Scientific Resources is the world's most recognized brand in Scientific Staffing with more than 100 locations in the North America, Europe and the Pacific Rim. Our scientists contribute to the research and development of products that are used daily in the home, such as medical devices or pharmaceutical products. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. We currently have an exciting opportunity in the San Francisco area as a Clinical Biosample Associate/ Manager.

**Objective of Position**

+ The Clinical Biosample Operations Associate / Manager oversees activities of collection, delivery and assay of biosamples including Biomarkers, PK and PD within clinical studies
+ The Clinical Biosample Operations Associate / Manager delegates tasks, establishes workflows and timelines for analytical needs to support corporate goals
+ To ensure biosample process consistency across all clinical studies within their respective projects and manages sample logistics from patient to data.
+ Collaborates with Translational Science Strategist and stakeholders of all levels to ensure sample management consistency and appropriate delivery and completion of tasks
**Essential Duties/ Responsibilities**

+ Initiate contracts and budget negotiations with vendors, manage and track tasks, facilitate discussions with stakeholders, and push through with deliverables to ensure finalization is within appropriate timelines
+ Liaises with translational and pharmacokinetic scientists and clinical teams to establish analysis needs with clinical feasibility
+ Collaborates with business partners and stakeholders on demands and expectations for all functions involved in the project
+ Establish productive working relationships with sites, vendors, business partners, and other stakeholders
+ Serve as an active member of the Clinical Study Team to obtain and provide updates on the progress of the trial in regards to sample management
+ Must be able to identify and mitigate risks to ensure accuracy in sample collection, delivery, and analysis
+ Keep track of follow up items for sample activities within clinical studies
+ Draft and review laboratory manuals to ensure accuracy and consistency with the study protocol and clinical needs
+ Manage Lab in PD sample logistics which involve sample delivery, query resolutions, negotiating with couriers and external vendors to streamline sample collection and shipment
+ Facilitate sample shipments and query resolutions among vendors to ensure timely data delivery as needed
+ Manage Pharma biobank
+ Identify issues and be proactive in urgently escalating and resolving them
+ Track and manage all sample related activities or PK, PD, and Biomarkers routinely and provide updates when appropriate
+ Have a strong understanding of scientific needs as well as clinical processes to bridge the needs between these functions
+ Understand and assist in data reporting needs for each clinical study

+ Excellent communication skills and ability to consistently keep track of all tasks
+ Maintain professional demeanor under stressful situations
+ Must be very diligent and extremely organized
+ Proven record of successfully managing multiple competing priorities
+ Self-motivated and a quick learner who’s able to take on tasks with minimal direction
+ Must have a strong research and clinical background
**Education/ Training**

+ Life sciences degree and a minimum of 6 years working experience in the biotech/pharma industry
+ Proven clinical development experience working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site
+ Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
+ Proven critical reasoning skills including the identification and resolution of complex problems
+ Proficient in Microsoft Office Applications including Excel, Word, and PowerPoint
Direct Hire role

Please apply now for immediate consideration!

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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