Translational Sampling Manager
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.
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.
- 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.