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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.
About the Role
Key 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
Essential 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)
Desirable Requirements:
- 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
The 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.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
