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Job Details

Clinical Biomarker/Biosample Project Manager

Company: CTC Resourcing Solutions
Location:
Reference: 896122-P
Closing Date: 15 Feb 19
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase Ib-IV)

Requirements:

For our pharmaceutical clients in Switzerland we are constantly looking to connect with experienced professionals in several areas, including pre-clinical development, clinical research, medical affairs, regulatory affairs, etc.

One of the roles we often recruit for is a Clinical Biomarker/Biosample Project Manager. In this role you will plan, coordinate and supervise all operational activities required to manage the lifecycle of biomarkers/ bio samples (including the collection, shipment, processing, analysis data delivery process and final sample disposition) and data delivery of patient samples (non-safety or PK related) within a clinical study or an academic collaboration.  The role requires strong scientific background and clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples. In addition, experience in clinical trial project management and Oncology therapeutic area as well as working in global cross-functional environment will be essential for the role.

Main Responsibilities

  • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase Ib-IV)
  • Provides biomarker operational expertise and guidance to one or more cross-functional global study teams
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples, collection, processing, analysis, data delivery process and final sample disposition).
  • Responsible for collaborating closely with biomarker scientists and biomarker operations leaders  to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple study teams,  and with internal and external stakeholders.
  • Develops and maintains effective working relationships with study team  members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
  • Delivers the operational elements of the biomarker management plan
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Identifies areas of best practice and process improvements; may lead or be a representative on functional groups goals, initiatives and work-streams
  • Ensures study and biomarker operational adherence to ICH/GCP and SOPs

Qualifications and Experience

  • 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
  • Experience with Oncology
  • Extensive clinical development experience with evidence of working in teams running clinical studies
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Project management skills and global Vendor Management experience preferred
  • Critical reasoning skills including the identification and resolution of complex problems
  • Fluency in written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: Clinical Biomarker/Biosample Project Manager

Contact Information:

Address:  Head Office
Münchensteinerstrasse 41
4052 Basel
Switzerland
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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