For our client, a globally active pharmaceutical company in the Basel area, we are looking for a temporary assignment as a:
Biomarker Operations Project Manager
As a member of global Study Communities, the Biomarker Operations Project Manager ensures the timely and efficient delivery of all biomarker operational aspects of multiple Oncology clinical studies (PhIb-IV) supported by Product Development.
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.
The ideal candidate is someone with a scientific education, around 3 year of experience with a minimum of 1 year in clinical operations in pharma. We are looking for a strong candidate able to came in and quickly support. This person should have good experience with vendor and project management working in a global matrix environment. Experience with biomarker in a pharma and clinical setting would be appreciated.
The ideal candidate is able to be independent, good communications skills & team player. Someone able to navigate a large matrix, global environment.
Tasks & Responsibilities:
- Ensures 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) 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 adherence to ICH/GCP and SOPs
- Min Bachelor/Master in Life Sciences (biology and/or chemistry) (PhD & Post Docs are considered)
- Minimum 3 years of experience, with at least 1 year working in pharma and clinical operations
- Experience working in a global and matrix environment
- Strong experience with vendor and project management
Nice to haves:
Working with biomarkers & bio samples in pharma
Start date: ASAP
End date: 30.11.2021
Work location: Basel
Remote/Home Office: home office mostly at the moment, onsite potentially needed in the next months. To be discussed when in position.
Department: Clinical Operations Oncology (MDGOAJ)
Please apply online. For further information about the position, please contact your Kelly recruiter, Judith Atgé Martin (+41 61 270 80 16).