 General Information
MGM Clinical Trials and Training Center (MGM-CTC) is a flagship department of the Sri Balaji Vidyapeeth (Deemed-to-be University) located in Pondicherry, India. The MGM-CTC has an excellent track record of successfully completing national and international clinical trials in different areas and across multiple phases.
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.
Interested candidates fulfilling the qualifications are requested to review the job descriptions and apply as mentioned below:
- The last date of application is 15 days from the date of publishing this advertisement
- The upper age limit of the applicant shall be not more than 50 years on the last day of application.
- All applications received online will only be entertained. For this, a detailed CV along with a two-page expression of interest may be submitted by mailing to [email protected].
- Canvassing in any form is strongly discouraged.
- Only the shortlisted candidate will be called for an interview and the same will be intimated to the email id provided by the candidate
- The decision made by the management, Sri Balaji Vidyapeeth (Deemed-to-be University) will be considered final.
Essential Qualification
- MBBS/MD/ DM in Pharmacology or Master’s degree in pharmacy with pharmacology or clinical pharmacy.
- 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.
Desirable Qualification
- Experience with global clinical studies.
- Previous experience managing vendor contracts and budgets
- Strong organizational and project management skills, including the ability to multitask and organize/track information
- Strong working knowledge of the drug development process, GCP, ICH guidelines, and national and international regulations covering clinical trials
- Proactive recognition of issues as they arise with resolution and/or appropriate escalation to management as warranted
- Excellent interpersonal, written, and verbal communication skills
- Strong computer skills and a high level of proficiency with Microsoft Office
Job Responsibilities
The Head, MGM Clinical Trials and Training Center, Sri Balaji Vidyapeeth (Deemed-to-be University) will be responsible for the overall operation of the Center at the University and shall lead in enhancing clinical trial businesses as a sustainable revenue generating model for the University.
The overall job responsibilities shall include:
- 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 sponsors audits; sponsor, investigator and regulatory queries, etc.
- Develop and organize capacity building programs including coursework, training modules, workshops, seminars, 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.
