Senior Vice President - Clinical Research

Senior Vice President - Clinical Research

Reports to: Chairman-Sami-Sabinsa Group

Job Overview:

The role of Senior VP involves delivering clinical research objectives by conceptualizing, reviewing, analyzing, developing & implementing Clinical Project.

Essential Duties and Responsibilities

- Streamline department activities and ensure consistent clinical trial execution.

- Interact with different departments like FND, Biological R&D, regulatory, finance and audit teams and external vendors like clinical labs, hospitals, DM and statistics services provider, publication houses.

- Ensuring compliance with Scientific engagement principles and standards in all activities and ensure that all governance activities are managed proactively.

- Manuscript writing and publication of clinical study data in reputed journals.

- Act as an operation and project manager for clinical trial and contribute to quote preparation for all proposed cost estimates study details.

- Responsible for all clinical and regulatory requirements i.e., ICH-GCP, Schedule Y, ICMR guideline for clinical trials. Monitor the preparation and review of clinical part of dossier for international & domestic submission as per regulatory requirements.

- Reviewing and finalizing protocols, Clinical study reports for clinical trials and resolving technical queries of sponsors, Ethics committees, DCGI and investigators.

- Managing periodic safety update reports

- Handling budgets and financials

- Improving operational systems, processes, and policies in support of organizations mission.

Qualifications

Educational level: M. Pharm., Ph.D.

Work Experience: 14-16 years' experience in clinical research, medical writing, and regulatory overview.