Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of manufacturing and selling of several drugs with treatment of Cancer. We are currently looking for an enthusiastic Biomarker Operations Specialist for a 12 months contract to be based in Basel.
The perfect candidate is someone with strong project management experience, someone that has worked within sample management before. Someone used to interact / manage clinical sites, CROs, sponsor sites or study teams. This position is on a project level rather than a study one. This means the successful candidate will be overseeing multiple studies at a time
- To provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme
- To ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels
- To implement the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery
- To be accountable for project level oversight (from feasibility to study close) of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable
- Leads cross-functional operations team meetings as required to ensure optimal delivery of project biosampling objectives
- To actively promote knowledge sharing within Clinical Operations and across studies within a project by partnering with stakeholders.
- To be accountable for the accurate and timely forecasting and management of individual project and study variable costs related to bio-sampling, in collaboration with key stakeholders
- To provide regular project/study level biosample status updates to key stakeholders as required.
- To act as a subject matter expert within the Clinical Operations for specific business related topics or processes
- To contribute to, and occasionally lead, functional process and system improvements to ensure operational excellence
- Mentor others as required to maximise their capability and contribution to deliver high quality biosamples
- Partner with cross functional parties and external vendors to communicate and train on relevant processes which underpin the laboratory operating model
- To contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels through role modelling the Roche values of courage, passion and integrity
- Ensures implementation of the ethical and legal framework for biosampling
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Minimum 3 years’ experience in project management
- Experience in sample management: leading and managing biosample operational activities on a range of logistically complex multi-centre clinical studies
- Experience interacting and managing important clinical stakeholders (e.g clinical sites, CROs, study teams or sponsor sites)
- Scientific degree & strong biomarker understanding (someone who worked in labs is advantageous)