Principal Scientist, Bmd Study Coordinator And Bmd Study Expert (bsc/bse) Biomarkers

Novartis

Hyderabad, India
Clinical study setup and coordination
Biomarker and pk sample management
Vendor and external service provider management
The role provides end-to-end operational support to clinical studies focusing on biomarkers and PK samples, ensuring high-quality data delivery to enable timely decision making and drug registration

Job Summary

  • The role provides end-to-end operational support to clinical studies focusing on biomarkers and PK samples, ensuring high-quality data delivery to enable timely decision making and drug registration.
  • The position involves partnering with clinical teams and external service providers to implement and monitor biomarker assays and sample flows across multiple biomarker modalities.
  • The candidate will lead best practices, process improvements, and innovations in sample, vendor, data, and assay monitoring functions while managing interactions with external CRO partners.

Matching Summary

The role provides end-to-end operational support to clinical studies focusing on biomarkers and PK samples, ensuring high-quality data delivery to enable timely decision making and drug registration.

Skills & Requirements

Must-have

  • clinical study setup and coordination
  • biomarker and PK sample management
  • vendor and external service provider management
  • biomarker assay implementation and monitoring
  • clinical data flow management
  • risk management and troubleshooting
  • collaboration with clinical and lab teams

Nice-to-have

  • global project management skills
  • proactive planning and problem solving
  • continuous improvement initiatives
  • matrix environment experience
  • knowledge of drug development process
  • strong communication and influencing skills
  • curious mindset

Key Requirements

  • 5+ years clinical operations or bioanalysis experience
  • Advanced degree with 3 years relevant experience
  • M.Sc. in Life Sciences or equivalent
  • Fluent English language skills
  • Knowledge of ICH/GCP and GLP regulations
  • Experience managing external service providers
  • Operational knowledge of clinical trials

Work Rights

Not specified

Tailored Resume

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