Biomarker Clinical Operations Lead in PDG

EINFÜHRUNG: Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting. For our client F. Hoffmann - La Roche in Basel, we are looking for a motivated and reliable (m/f/d) Biomarker Clinical Operations Lead in PDG 100%AUFGABENBESCHREIBUNG: Provide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data deliveryBe accountable for the development of the BIOMARKER MANAGEMENT PLAN and the execution of deliverables for assigned drug and device studies (e.g. IVD clinical performance studies) in partnership with the Clinical Study Lead or designeeManage all study level biomarker operations activities for both clinical (i.e. drug) and IVD studies (e.g. manage vendor/testing sites, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality and transfer set-up)Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, shipping conditions and logistics for biomarker samplesLead identification, selection and oversight of BIOMARKER VENDORS, including development and oversight of scope of work, budget, ensuring quality delivery and performanceActively partner with Data Management to oversee and coordinate biomarker data format and delivery timelinesCollaborate and partner with cross functional stakeholders (e.g. study team members, biomarker science, CDx, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker/IVD operational strategies, serving as a single point of contact for biomarker/IVD operations on multiple study teamsProvide technical knowledge of aspects related to biomarker analyses (e.g. sample collection and handling, assay, device and imaging technologies)Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring adherence to ICH/GCP, SOPs, ISO 20916 and regulatory requirementsAttend operations team meetings and investigator/monitor meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection, handling and IVD proceduresProvide responses to biomarker sample/IVD related questions or issues from Health AuthoritiesIdentify areas of best practice and process improvements and contribute to/lead initiatives (if requested)You will work on business priorities as directedExpectation of ongoing and sustained onsite presence in compliance with local requirementsERFORDERLICHES PROFIL: Minimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area). Further qualification, e.g. PhD and/or project management certification is desirable 3+ years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment ? Industry experience required Extensive clinical development experience with evidence of working in teams running clinical studies Strong experience with vendor and project management Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelinesHave a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samplesExperience working in a global and matrix environmentExcellent collaboration, communication, influencing and presentation skillsCritical reasoning skills including the identification and resolution of complex problemsDetail oriented with the ability to work independently and manage multiple competing prioritiesFluency in English with additional language skills as an assetStart date: asap - latest: 01.11.2025 Planned duration: unlimitedRemote/Home Office: to be discussed, up to 2 days per weekAre you interested and would you like to seize this opportunity? Then we should definitely get to know each other Simply click on "Apply now" and we look forward to receiving your complete application documents.