**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Senior Bioanalytical Study Manager** **Role Overview:** Join our dynamic team and lead the charge in supporting AstraZeneca's Development pipeline from a bioanalytical perspective. You'll manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data by coordinating activities between multiple stakeholders. **Key Responsibilities:** + **Vendor Management:** Lead the contracting with third-party lab service providers for assay development and validation. Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts. + **Study Coordination:** Manage critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines. Support the development of novel Bioanalytical processes. + **Documentation & Data:** Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs). Drive the delivery of data transfer specifications and ensure data accuracy. + **Sample Logistics:** Track and reconcile sample testing, resolving any issues that arise. Contribute to cleaning and finalizing data. **Qualifications:** + **Education:** BA/BS or higher in medical science or a related field, plus 4+ years (BA/BS) or 2+ years (MS) of clinical trial management experience. + **Experience:** + Familiarity with clinical bioanalysis outsourcing operations. + Knowledge of GLP, GCP guidelines, and vendor audits. + Understanding of clinical trial design and data outputs. + Experience with sample collection instructions and lab manuals. + Proficiency in data transfer agreements/specifications and data reconciliation. + **Skills:** + Strong organizational and analytical skills. + Excellent written/verbal communication. + Ability to work both independently and as part of a team. + Proficiency with Excel and other interactive programs. **Why Join Us?** + **Innovative Environment:** Work on cutting-edge projects in a collaborative setting. + **Professional Growth:** Opportunities for learning and development. + **Impactful Work:** Contribute to life-changing clinical trials and research. **Apply Now and Make a Difference in Bioanalysis!** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.