Recruitment Specialist at Cadence Connections
Views:130 Applications:15 Rec. Actions:Recruiter Actions:1
Senior Vice President - Clinical Research (14-17 yrs)
Senior Vice President - Clinical Research
Reports to: Chairman-Sami-Sabinsa Group
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.
Educational level: M. Pharm., Ph.D.
Work Experience: 14-16 years' experience in clinical research, medical writing, and regulatory overview.