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Biosample Manager (m/w)

Posted on Mar 17, 2019 by Docs Global (Continental Europe)

Darmstadt, Hessen Germany
Research & Development
12 Mar 2019
Annual Salary
Full-Time
Job Summary For one of the Top 4 global players in the pharmaceutical industry DOCS is hiring a Biosample Manager (m/f) in Germany. If you have experience in clinical research and want to develop further into driving biosample logistics within clinical trials in a globally successful pharmaceutical company, this might be for you. Roles & Responsibilities of the position • Responsible for managing logistical set up and operational implementation of Biosample / translational research activities in a clinical study. • Responsible for supporting training (initial and ongoing), mentoring and operational activities of the Clinical Trial Management Biosamples Team; Mentor others as required to maximize their capability and contribution to deliver high quality biosamples • Oversees preparation of documentation and materials necessary for biosample collection, in conjunction with external logistics provider (including Laboratory Manual, Material Request Forms, Biosample Collection/Labeling Forms, Sample Clarification Forms, Sampling Kits) • Plans and performs tasks related to biological sample collection in an independent manner, with supervision by Head of CTBM and in collaboration with CTL and CRO • Oversight of samples shipment from study sites to logistics provider and from external logistics provider to analytical laboratory for analysis and sample availability (received / shipped) in the sample tracking system • Ensure the Clinical Trial Management Biosamples Team consistently implement standardized processes for maximizing sample accrual and quality across clinical trials and therapeutic areas, and is responsible for oversight of the Clinical Research Organization when applicable Job Requirements • Bachelor degree (or equivalent) in life sciences (e.g. biology, chemistry, pharmaceutics) or medicine, or a related medical field • At least 2 years of experience in a clinical project management function • Profound experience in leading and managing biosample operational activities essential on a range of logistically complex multi-location clinical studies are welcome; clinical trial planning and start up (including budget & resource planning) desirable • Advanced knowledge of ICH-GCP, other relevant guidance documents (from ICH, FDA, EMEA etc.), and of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries • Project management skills desirable, willing to take on and lead special projects, able to identify risks and problems and to propose appropriate measures when required • Excellent IT, presentation, time management and interpersonal skills • Fluent English and German language skills Remuneration & other details • Permanent contract with DOCS • Full time, office or home based in Frankfurt area • Great pipeline of studies -> very good long term perspective • Top 4 global player in the pharmaceutical industry • Pension scheme Why this vacancy is right for you: We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life. Interested? Please submit your CV to or call me on (0) . We are looking forward to your application.

Reference: 672603877