Job Description

Translational Sampling Manager

- Pharmaceuticals
Posted by Katleen Broeckhoven on 17/10/2019

For a main player in the pharmaceutical field, we are looking for a Translational Sampling Manager with expertise in a life science laboratory and extended Clinical Operational knowledge in ED. Please find out more below and on www.novellashealthcare.com and apply when passioned about this position.

MISSION

The Translational Sampling Manager has a key role in introducing new sampling platforms to assess novel biomarkers in clinical studies related to the company’s portfolio of new interventions in chronic HBV.

The TSM will use his/her experience and skillset in developing robust laboratory protocols for biological assays into an interventional trial setting, with a focus on the applicability and learnability in a clinical study site setting.

He/she will engage and guide specialized vendors to provide consistent trial support and integrate the additional complexity into the established vendor support pipeline with clear communication towards the internal stakeholders.

RESPONSIBILITIES

  • Introduce new sampling platforms into early and full development clinical trials.
  • Provide clear protocols, instruction manuals and tailored operational learning templates for the sites to consistently adopt the new sampling platforms.
  • Define and implement the logistical chain from sample to centralized data generation in a well-articulated operational relationship to the established vendor support pipeline.
  • Work to integrate efficiently the operational aspects of new platforms in clinical protocols in solid concertation with development team members responsible for the application of established biomarkers and sampling procedures.
  • Provide support for educational and scientific communications towards internal development teams and external investigators.
  • Provide clear budgeting and forecasting information on the platform process components to the Translational Medicine Department.
     

QUALIFICATIONS & REQUIREMENTS

  • PhD in Life Sciences
  • Hands-on work and organisational expertise in a life science laboratory
  • Minimum of 5 years of
    • clinical trial experience in ED environment in the pharmaceutical industry or CRO.
    • working in a matrix organization, including in an international and virtual setting.
  • Strong expertise in vendor management.
  • Clinical-Operational knowledge in ED is a must
  • Clinical-Operational knowledge in FD is an asset
  • Experience with start-up vendors is an asset.
  • Pre-existing knowledge about cell sorting, sequencing and histochemistry techniques is an asset.
  • Excellent knowledge of English
  • Willingness and ability to travel up to 15-20% of the time, defined by business needs.

 

COMPETENCES & SKILLS

  • Strong problem-solving skills while maintaining high standards of quality, ethics and compliance.
  • Ability and flexibility to prioritize and to work in a matrix organization under pressure with short timeframes for deliverables
  • Strong organizational skills to cope with multi-tasking which result in a goal-oriented approach without losing the attention to details.
  • Good communication skills in setting clear objectives, persuading others to accept new approaches and gaining alignment on divergent issues
  • Solid skills toward providers in
    • clearly defining company objectives
    • negotiating fit-for-purpose agreements
    • identifying imaginative solutions to provide a path forward when confronted with new challenges.
  • Demonstrated expertise in working cross-culturally.

 

Similar Vacancies