Biomarker Study Coordinator, Senior Scientist II

Novartis • Cambridge, MA

4d • Hybrid

About The Position

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. #LI-Hybrid Internal Title: Senior Scientist II Location: Cambridge This 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.

Requirements

• PharmD, M.S. or Advanced degree in clinical study management with 1+ years of relevant experience
• Good understanding of the drug development process and clinical study operations
• General 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 sites
• Experiences 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 evolves
• Strong attention to details, project management, problem solving and excellent communication skills
• High energy, initiative, excellent time management, and multi-tasking skills
• Hands-on experience with AI/ML tools (e.g. MS Copilot Studio, Knime, Python)

Nice To Haves

• Experience working and managing external collaborations or external workflow (eg partners/CROs) is a plus
• Pharm D highly desirable
• Experiences 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 desirable

Responsibilities

• Review study protocol, prepare protocol sections relevant for biomarker sample logistics
• Prepare biomarker informed consents, review site changes for informed consents
• Prepare biomarker sample collection tables
• Prepare Novartis lab manuals by coordinating input from biomarker labs
• Review and provide input into Central Lab protocols/manuals
• Prepare documents related to sample shipments to/from external CROs
• Provide support for biomarker plan review and biomarker budget estimates
• Review biomarker section for study eCRF
• Update study information in relevant IT systems
• Collaborate with clinical teams and biomarker experts on study planning and execution
• Serve 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 data
• Lead or contribute to process improvement projects, including the use of AI/ML tools

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees