Job Title:
Reports To: Clinical HOD
Role Summary
The Senior Manager – Clinical Operations will be responsible for overseeing the end-to-end execution of clinical studies conducted at Mascot Spincontrol. The role involves leading clinical operations teams, ensuring study timelines and quality standards are met, maintaining regulatory compliance, and serving as a key operational partner to the Clinical HOD. The incumbent will drive efficient study conduct while ensuring the highest standards of participant safety, data integrity, and client satisfaction.
Key Responsibilities
Clinical Study Management
- Oversee the planning, initiation, execution, monitoring, and closure of clinical studies.
- Ensure studies are conducted in accordance with approved protocols, SOPs, GCP guidelines, and applicable regulatory requirements.
- Monitor study progress, timelines, deliverables, and resource allocation to ensure successful project completion.
Team Leadership & Management
- Lead, mentor, and manage the Clinical Operations team.
- Allocate resources effectively across multiple studies and projects.
- Conduct regular performance reviews, training, and development initiatives for team members.
Client & Stakeholder Management
- Serve as a key point of contact for sponsors, clients, investigators, and external stakeholders.
- Participate in client meetings, project reviews, and business discussions as required.
- Ensure timely communication of study updates, milestones, challenges, and resolutions.
Quality & Compliance
- Ensure adherence to GCP, ICH guidelines, SOPs, and applicable regulatory requirements.
- Support audits, inspections, and quality assurance activities.
- Drive CAPA implementation and continuous process improvements.
Operational Excellence
- Develop and implement processes to improve study efficiency and quality.
- Monitor study budgets, resource utilization, and operational performance metrics.
- Collaborate with cross-functional teams including Regulatory, Data Management, Biostatistics, and Quality Assurance.
Strategic Support
- Support the Clinical HOD in achieving departmental goals and business objectives.
- Contribute to process development, operational strategy, and departmental growth initiatives.
- Assist in business development activities, feasibility assessments, and operational planning when required.
Qualification & Experience
- Master's degree in Life Sciences, Pharmacy, Clinical Research, or related field.
- 4 to 5 years of experience in Clinical Research/CRO operations.
- Proven experience in managing clinical studies and leading teams.
- Strong understanding of clinical research regulations, GCP, and study conduct requirements.
- Experience in sponsor/client-facing roles is preferred.
Pay: ₹40,000.00 - ₹70,000.00 per month
Benefits:
- Cell phone reimbursement
- Food provided
- Health insurance
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
