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Novartis

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4.1

based on 1.5k Reviews

232 Novartis Jobs

Senior Scientist II

Novartis Healthcare Pvt. Ltd.

4.1

based on 1.5k Reviews

4-8 years

Hyderabad / Secunderabad

1 vacancy

Senior Scientist II

Novartis

posted 11d ago

Job Role Insights

Flexible timing

Key skills for the job

Logistics Outsourcing Clinical Research Operations Clinical Data Management GCP

+ 4 more

Job Description

Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (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

Your responsibilities include, but are not limited to:

Independently provide operational support to Biomarker Study Experts and clinical studies focusing on biomarker samples and including reviews of clinical study protocol, preparing site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample operation logistics and coordination including study setup, sample tracking/reconciliation, assay and vendor set up, sample/data upload and study closure
Support data transfer and data flows in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies.
Update study and project information in relevant reports and IT systems
Independently identify and resolve sample management and sample discrepancy issues
Identify, and escalate issues, ESP, quality or performance issues and engage LF experts/SME, clinical trial leaders and data management as needed.
Contribute to the best practices, process.
Continuous improvement initiatives and innovations in sample management functions
Collaborate with other TM, BMD and GCO functions

BS in life science with 4+ years of clinical operations experiences and/or clinical bioanalysis and/or clinical biomarkers. Advance degree with 2 years in clinical operations and/or clinical bioanalysis and/or clinical biomarkers

Operational knowledge of clinical trials: clinical study set up, clinical sample management, clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors
Laboratory background and knowledge immunoassay and/or bioanalysis
Knowledge of the drug development process, clinical biomarkers and working with translation clinical research.
Strong project and time management skills, problem solving, communication and leadership skills.
Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc.