Senior Scientist

Novartis -
Hyderabad, Telangana

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Job details

Full-time
5 days ago

Qualifications

Master's degree
Project management
Genetics
Clinical trials
Communication skills

Full job description

Summary

Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions Laboratory Excellence and Operation (LEO) and Biomarker Science and Op-eration (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites

About the Role

Key Accountabilities

Provide operational support to clinical studies focused on biomarkers, safe-ty and PK samples, including clinical study setup, sample tracking/reconciliation, assay and vendor coordination, sample/data upload support and study closure activities. Responsibilities include supporting the re-view of clinical study protocols, site operations manuals, informed consent forms, sample collection tables, instruction manuals, central lab proto-col/manual, eCRF-related content, and other biomarker sample operation logistics.
Serve as a BMD Study Coordinator/ and clinical team representative from BMD on selected clinical studies and/or at a project level.
Partner with clinical teams, data management, central labs, vendors, and internal functions to support biomarker and PK sample related activi-ties.Independently set up central lab and central lab services (specifications, clinical sites, samples, assays),
Implement and monitor biomarker/PK sample flow across BM modalities (e.g., Immunoassay, LC-MS, Flow cytometry, genetics etc.) and PK assays
Maintain and update study and project information in relevant reports, trackers, dashboards, and IT systems.
Identify and escalate sample management, assay, vendor, data, quality or performance-related issues and to senior team members, subject matter experts, clinical trial leaders, and data management teams as appropriate.
Contribute to process improvements, best practices, process and continuous improvement initiatives within sample, vendor, data and assay monitoring activities.
Collaborate across Translational Medicine functions, central lab, clinical sites, and vendors to support efficient study execution, aligning with defined LEO processes.

Essential Requirement

Master’s degree (M.Sc.) in Life Sciences or advanced degree in Clinical Operations, Clinical Bioanalysis, Biomarkers, or related field, with ~3+ years of relevant clinical operations experience.
Operational knowledge of clinical trials: clinical study set up, central lab set up, clinical sample management, clinical data flows (e.g. DTS) clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors
Knowledge of the drug development process, clinical biomarkers, clinical data management and working with translation clinical research is a plus
Strong global project management, proactive planning in clinical studies, problem solving, influencing, and communication skills.
Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc

Desirable Requirement

Laboratory background, knowledge of bioanalysis, are desired.
Experience working in a global organization and matrix environment (multiple roles/connections and stakeholders) is a plus.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Division

Biomedical Research

Business Unit

Research

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

Accessibility and accommodation

Novartis is 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 recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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Summary

About the Role

Accessibility and accommodation

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