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Sample Acquisition Manager

Employer
Perkin Elmer
Location
Waltham MA US
Closing date
Dec 25, 2017

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
The Position
We are seeking a highly motivated individual to join PerkinElmer Inc. Medical and Scientific Affairs function. The individual will support R&D and the clinical study team in management of sample vendors, sample logistics and provide bio-sample acquisition and operational expertise to the study team and other stakeholders.
Key responsibilities include:
  • Responsible for the identification, selection and oversight of biobank vendors including drafting RFPs and defining scope of work in support of study objectives and goals.
  • Establish and develop a global sample acquisition network by actively seeking new sources for samples in close collaboration with business and sales organizations; prepare and maintain a list of potential sample sources
  • Accurate forecast and track timeline and costs associated with sample acquisition payment, logistics and shipment.
  • Participate in protocol, informed consent form, and CRF development to ensure sample information and logistical feasibility of biological sampling alignment with ICH/GCP, appropriate policies, procedures, and sample testing plans
  • Act as a primary contact and communication channel for sample providers.Prepare required documents, IRB applications, agreements, etc.
  • Provide regular sample acquisition metrics and status updates to the project team. Investigate and address discrepancies detected from the sample metrics with the study manager and recommend effective solutions.
  • Maintain and archive appropriate documentation for the sample acquisitions.
  • Partner with the study manager to plan, organize and oversee the packaging, labeling and shipping of samples from the biobanks or centralized locations and subsequent delivery to assay laboratories in accordance with study timelines.
  • Prepare and develop sample acquisition processes
  • Maintain and update knowledge of global regulatory requirements concerning sample acquisitions and their use in product development, monitor the development of regulations and communicate impact to the company
  • Provide adequate sample acquisition training and guidance to the study managers and internal cross functioning stakeholders.

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