The MGM-CTC invites applications from motivated and subject matter experienced Indian nationals to fill the post of Head of the Center. Remuneration will be commensurate with the experience as per the industry standards.

• Take charge and lead the ongoing operation of the MGM Clinical Trials and Training Center, Sri Balaji Vidyapeeth (Deemed-to-be University) including the clinical trials that are ongoing and are in pipeline.
• Serve as point of contact for all key stakeholders while maintaining and managing the relations with the sponsors, clients and the clinical investigators.
• Expand the clinical trial portfolio by identifying suitable trials, communication and on boarding of the sponsors, investigators and clients.
• Manage operational aspects of clinical trials from study start-up through database lock, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements. Ensure compliance with SOP and GCP for all projects in close coordination with the QC team
• Review the study appropriateness and give technical input for study execution and handle the sponsor’s monitors.
• Oversees performance of team members in either a matrix management model and/​or as direct reports on their management of study deliverables, and actively provides operational direction and/​or general supervision.
• Develop and manage study budget and timelines with clear assumptions.
• Develop, validate and implement stringent risk assessment and risk management plans at the Institutional level.
• Handled regulatory inspections and sponsor audits; sponsor, investigator and regulatory queries, etc.
• Develop and organize capacity building programs including coursework, training modules, workshops, seminars, and symposiums in areas of clinical trials and training under the University Umbrella
• Provide frequent study updates to senior management upon request requirements.
• Any other duties assigned from time to time by the management.

MBBS/MD/ DM in Pharmacology or master’s degree in pharmacy with Pharmacology or clinical pharmacy with 5 years of experience in co-ordination/ documentation and management of clinical trials.

• Minimum 5 years of experience in co-ordination/ documentation and management of clinical trials with large company or 10 years with smaller company.
• Excellent understanding of GCP and regulatory requirements related to clinical trials, data management systems and associated activities.

Interested candidates can send your updated CV to vpoffice@​sbvu.​ac.​in

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