You will work closely with Translational Research, Clinical Development, Clinical Operations, Clinical Pharmacology and Bioanalytics, Data Management, Biostatistics, Regulatory Affairs, Legal/Procurement, external laboratories, central laboratories, and CROs to support robust operational delivery of the clinical biomarker & bioanalytical program.
Your responsibilities include:
- Drive the operational implementation and execution of clinical biomarker, translational sample, and bioanalytical activities across ongoing clinical trials.
- Support planning and take responsibility for execution of biomarker-related trial activities, including sample collection, processing, shipment, tracking, reconciliation, laboratory testing coordination, and data transfer.
- Be responsible for the development, maintenance, and updates of biomarker- and bioanalytics-related sections of clinical trial documents, including protocols, laboratory manuals, sample handling instructions, vendor scopes of work, study plans, and relevant operational or regulatory documents.
- Lead operational set-up activities, including vendor identification, vendor qualification, contracting support, study start-up, sample logistics, assay readiness tracking, data transfer processes, and report delivery.
- Oversee external vendors, specialty laboratories, central laboratories, CROs, and other service providers involved in sample handling, biomarker testing, bioanalytical testing, data delivery, and reporting.
- Ensure biomarker and bioanalytical activities are executed according to study timelines, quality expectations, contractual agreements, protocol requirements, and relevant regulatory and GCP standards.
- Track operational milestones, risks, issues, and dependencies, and proactively drive resolution in collaboration with internal functions and external partners.
- Review vendor deliverables from an operational and quality perspective, including laboratory manuals, sample reconciliation outputs, data transfer files, status reports, and final reports.
- Facilitate cross-functional communication between internal functions, external partners, clinical sites, central laboratories, and specialty laboratories.
- Maintain clear documentation of operational plans, decisions, vendor communications, sample status, data transfers, contracts, study-level deliverables, and open issues.
- Support budget tracking, purchase orders, contracts, change orders, and invoice review for biomarker- and bioanalytics-related vendors.
- Contribute to continuous improvement of biomarker and bioanalytical operations processes, templates, vendor oversight practices, and cross-functional ways of working.