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Biosample Operations Specialist

Hertfordshire   •  Contract/Temporary, Full time

CK Group is recruiting for a Biomarker Operations Project Manager to join a global pharmaceutical company who are based in Welwyn Garden City on a contract basis for 12 months initially. The role has been determined as outside IR35, and working options are available as a Ltd company contractor, Umbrella company or PAYE via CK.

The Biomarker Operations Project manager will:
-Ensure the delivery of all biomarker operational aspects of one or more studies within the Oncology Therapeutic Area through all phases (phase 1b-IV) supported by Pharma Development
-Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
-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 Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
-Develops and maintains effective working relationships with SMT 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 adherance to ICH/GCP and SOPs.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Life sciences degree (bachelor or masters) in scientific, medical or healthcare area
- Further qualification, such as PhD and/or project management certification is desirable.
- Scientific/ laboratory background
- Clinical trials and drug development experience
- Project management and vendor management experience
- Good with data and using systems
- Oncology therapy area experience desirable but not essential
- 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 (patient samples to clinics)
- Planning, organisational and time management skills
- Highly flexible in a fast pace global matrix environment
- Professional interpersonal skills, excellent oral/ written communication and influencing skills
- Creates team culture and promotes team spirits
- Good knowledge of ICH GCP Competencies

For more information or to apply for this position, please contact Steve Lord on 01246 457733 or by email on slord@ckgroup.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign.

Entitlement to work in the EEA is essential. Please quote reference CL52182 in all correspondence.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Stephen Lord
  • Phone: 01246 457722
  • Reference: 52182
  • Posted: 12th November 2021
  • Expires: 10th December 2021

CK Group

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