Senior Oncology Specialist

6 days ago

Hyderabad Secunderabad Telangana, India beBeeClinical Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title: Clinical Medical Expert

Role Summary

This role focuses on providing medical leadership and support for global, roll-over, and long-term follow-up studies in the close-out phase. The successful candidate will also contribute to assigned aspects of a global, active study under the guidance of a Clinical Program Leader and/or Medical Expert.

Main Responsibilities
  • Support clinical program leaders and medical experts with medical input, including contributing to protocol sections, informed consents, publications, and regulatory documents.
  • Act as a medical monitor to ensure overall program safety reporting, collaborating with patient safety teams.
  • Contribute to TCO-related submission documents, including briefing books, investigator brochures, annual safety reports, and responses to health authority questions.
  • Ongoing review of clinical trial data, coordinating data analysis and interpretation across assigned TCO studies.
  • Support dose escalation meetings, investigator teleconferences, and site initiation visits.
  • Lead the close-out process for assigned studies, ensuring quality of clinical study reports (CSRs) in collaboration with CSR writing teams.
  • Maintain expertise in ICH-GCP, external regulations, and Novartis SOPs and internal policies.
Key Performance Indicators
  • Deliver high-quality medical input to assigned studies within timelines and adherence to international and local regulations.
  • Ensure quality medical and scientific review of clinical trial data.
  • Develop high-quality documents, including protocols, CSRs, and regulatory documents.
  • Contribute to departmental objectives and demonstrate feedback from stakeholders.
  • Demonstrate Novartis values and behaviors.
Requirements
  • Highly developed medical knowledge and skills in oncology.
  • Strong scientific writing and communication skills.
  • Ability to work collaboratively with cross-functional teams.
  • Expertise in ICH-GCP and external regulations.
  • Excellent problem-solving and analytical skills.

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