Bio Scientific Research Laboratories (I) Pvt Ltd invites applications for the position of Assistant General Manager (Clinical Head) in the Clinical Department.
Job Details
- Location: Mira Road, Mumbai
- Experience: 5 to 10 years
- CTC: As per industry standards
Principal Duties and Responsibilities
- Responsible for overall clinical operations and compliance.
- Conduct Clinical Study Feasibility Assessments to determine if study protocols are scientifically, technically, and ethically viable.
- Provide inputs for project budget preparation.
- Collaborate with subject experts to finalize study design and endpoints during protocol development.
- Handle regulatory and sponsor audits and inspections.
- Schedule clinical studies and prepare compliance documentation for regulatory/sponsor observations and queries.
- Coordinate with subject organizers for screening and enrollment of study participants.
- Manage project components, including:
- Sponsor-specific requirements
- Effective project planning and scheduling
- Resource allocation and budgeting
- Communication and tracking of progress
- Proactive resolution of issues
- Review and approve quality documents such as SOPs, change controls, deviations, laboratory incidences, and CAPA.
- Implement corrective and preventive actions for unforeseen errors affecting study quality and integrity.
- Assist in resolving non-compliance issues in coordination with external audits.
- Work with the QA department to address non-compliance during audits.
- Participate in management review meetings.
- Regularly update management on issues identified during sponsor audits.
- Provide updates on compliance levels and any compliance-related issues.
- Support other management activities as delegated.
- Handle tasks as assigned by the Director.
How to Apply
Interested doctors are encouraged to share their profiles via email:
📧 hr@biosrl.com
Advance your career by joining a leading organization in clinical research!
