Biomarker Study Coordinator, Senior Scientist II

Novartis Institutes for BioMedical Research is the global pharmaceutical research organization for Novartis committed to discovering innovative medicines that treat disease and improve human health.Biomarker Study Coordinator is part of Laboratory Excellence and Operation team which provides compliance, operational, sample planning/coordination, vendor management and data monitoring capabilities to other internal Novartis functions, including Biomarker Development, Translational Medicine, and Development General Medicines. Title: Senior Scientist IILocation: CambridgeThis role is based in Cambridge, MA. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.Key Responsibilities: Review study protocol, prepare protocol sections relevant for biomarker sample logisticsPrepare biomarker informed consents, review site changes for informed consentsPrepare biomarker sample collection tablesPrepare Novartis lab manuals by coordinating input from biomarker labsReview and provide input into Central Lab protocols/manualsPrepare documents related to sample shipments to/from external CROsProvide support for biomarker plan review and biomarker budget estimatesReview biomarker section for study eCRFUpdate study information in relevant IT systemsCollaborate with clinical teams and biomarker experts on study planning and executionServe as the SME and partner with BMD internal labs, sample management, clinical trial leaders and data management to develop best practices and resolve issues related to sample shipments, missing samples or sample dataLead or contribute to process improvement projects, including the use of AI/ML toolsEssential Requirements: PharmD, M.S. or Advanced degree in clinical study management with 1 years of relevant experienceGood understanding of the drug development process and clinical study operationsGeneral knowledge of biomarker and laboratory methodologies (bioanalytical, genetics, etc)Ability and skills to work effectively in parallel with many clinical teams and under deadlines across multiple R&D sitesExperiences and ability to reconcile clinical sample data are strongly desirable.Potential, and willingness to develop skills in new areas and lead new initiatives as the BSC function evolvesStrong attention to details, project management, problem solving and excellent communication skillsHigh energy, initiative, excellent time management, and multi-tasking skillsHands-on experience with AI/ML tools (e.g. MS Copilot Studio, Knime, Python)Desirable Requirements: Experience working and managing external collaborations or external workflow (eg partners/CROs) is a plusPharm D highly desirableExperiences and track record of clinical study management in a (bio) pharmaceutical industry or at CRO. Up to date knowledge of clinical sample management practices and regulations is strongly desirableThe salary for this position is expected to range between $98,700 and $183,300 per year.The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.To learn more about the culture, rewards and benefits we offer our people click here.