For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking for a
Biomarker Operations Project Manager 100%
Contract type: external temporary assignment
Start of assignment: asap (max. two months of notice period accepted)
Duration: planned for 12 months (extension possible)
In this role you are accountable for planning, coordinating and overseeing all operational activities required to manage the lifecycle of biomarker samples in accordance with time, cost and quality commitments including ICH/GCP and applicable regulations.
You collaborate closely with Biomarker Scientists and Biomarker Operations Program Leaders to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple study communities. You maintain effective working relationships with particular focus on the operational team, biomarker scientists, diagnostic partners, external CRO & central lab and external biomarker vendors. In addition, you provide clinical biomarker operational expertise, innovative and flexible operational solutions within day-to-day activities and in support of the biomarker operational plan.
Ideally, you are also able to identify areas of best practice and process improvements, as well as lead or be a representative on functional groups goals, initiatives and work-streams.
Tasks & Responsibilities
* Ensure the timely and efficient delivery of all biomarker operational aspects of one or more studies within the oncology therapeutic area through all phases (phase 1b - IV)
* Provide biomarker operational expertise and guidance to one or more cross-functional global Study Management 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 Program Leaders to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple Study Management Teams and with internal and external stakeholders
* Develop and maintain effective working relationships with Study Management Team members, with particular focus on the operational team, diagnostic partners, external CRO & central lab (for outsourced teams), and external biomarker vendors
* Manage the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
* Provide clinical biomarker operations expertise to ensure operational feasibility and delivery
* Deliver the operational elements of the biomarker management plan
* Provide the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
* Ensure study and biomarker operational adherence to ICH/GCP and SOPs
* University degree in Life Sciences (Biology and/or Chemistry)
* Minimum three years of experience, with at least one year in pharma and clinical operations
* Experience working in a global and matrix environment
* Strong experience with vendor and project management
* Experience with biomarkers and bio samples in a pharma and clinical setting would be appreciated
* Good communication skills (fluent in English)
Please apply online.
For further information, please contact Nicole Blum (+41 (0)76 567 26 82).