Assistant Manager - Clinical Research

JOB PURPOSE

The Clinical Research Operations Manager is responsible for the strategic and day-to-day management of all clinical research activities at the site. This role ensures operational excellence, regulatory compliance, team leadership and the efficient execution of all research projects.

Core Responsibilities

• Oversee the planning, execution, and close-out of all clinical trials conducted at the units of MHC.
• Ensure site readiness, protocol compliance and resource allocation for all ongoing and upcoming studies.
• Develop and implement SOPs and quality systems for clinical research operations.
• Ensure adherence to ICH-GCP, Schedule Y, NDCT rules, and institutional SOPs.
• Supervise the preparation and submission of documents to EC and regulatory authorities.
• Coordinate with Investigators, Sponsors, CROs and regulatory monitors for smooth operations in clinical research.
• Participate in feasibility assessments, budget negotiations and contract discussions.
• Facilitate site selection visits, SIVs and monitoring/audit visits.
• Monitor clinical trial budgets, ensure timely billing, invoicing, and fund tracking and payout to Investigators.
• Oversee financial compliance for investigator payments and operational costs.
• Oversee timely and accurate data collection, entry, and query resolution.
• Conduct periodic internal quality checks and corrective action implementation

Experience

• 3- 6 years of clinical research experience, including site management or project leadership
• Deep knowledge of regulatory requirements (GCP, ICH, NDCT, Schedule Y).
• Strong team managership, multitasking and organizational abilities.
• Excellent written and verbal communication skills.
• Proficient in CTMS, EDC platforms (e.g., RAVE, Medidata), and MS Office tools.