Clinical Research Manager - Full Time

Sunshine Manpower; Nagpur District; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Sunshine Manpower Solution & Services in Nagpur is seeking a Senior Operations Manager - Clinical Research to oversee operations across multiple studies and sites while ensuring ICH-GCP compliance. You will manage timelines, budgets, and dashboards, leading a team of Project Managers and CRCs.

The role requires strong leadership, regulatory knowledge, and hands-on experience with CTMS, EDC and eTMF systems, plus collaboration with PIs, sponsors, CROs and QA teams.

Qualifications

• 6–10 years of clinical research operations experience.
• Strong site management and study startup experience.
• Good knowledge of ICH-GCP and regulatory compliance.
• Proven leadership and stakeholder management skills.
• Experience with CTMS, EDC and eTMF systems.

Responsibilities

• Oversee clinical research operations across studies and sites.
• Lead start-up, site activation, conduct, and closeout processes.
• Track recruitment, timelines, milestones, and site performance.
• Coordinate with PIs, sponsors, CROs, QA and regulatory teams.
• Prepare dashboards and reports for senior management.
• Support audits, inspections, budgeting, and vendor management.

Skills

Clinical operations

Team leadership

Stakeholder management

Problem solving

Regulatory compliance

Communication

Education

Bachelor's degree in Life Sciences

Master's degree in Healthcare Management

Tools

CTMS

EDC

eTMF

MS Office

Job description

Sunshine Manpower Solution & Services does not take any service charge from the candidate or job seekers.

Position

Senior Operations Manager - Clinical Research

Experience

6-10 Years

Location

Nagpur

Key Responsibilities

• Manage clinical research operations across multiple studies/sites.
• Oversee study start-up, site activation, conduct, closeout and documentation.
• Track recruitment, timelines, milestones and site performance.
• Lead and guide Project Managers, CRCs and clinical operations teams.
• Coordinate with PIs, sponsors, CROs, QA and Regulatory teams.
• Ensure compliance with ICH-GCP, SOPs, protocols and regulatory requirements.
• Manage operational risks, deviations, CAPA and issue resolution.
• Review TMF/eTMF, CTMS, EDC, reports and study trackers.
• Prepare operational dashboards and reports for senior management.
• Support audits, inspections, budgeting, vendors and process improvements.

Qualifications & Skills

• Education: Bachelor's/Master's in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, Healthcare Management or related field.
• Strong clinical trial operations and site management experience.
• Good knowledge of ICH-GCP and regulatory compliance.
• Team leadership, stakeholder management and problem-solving skills.
• Experience with CTMS, EDC, eTMF and MS Office.

Experience 6 - 10 Years

Industry Pharma / R&D / Biotech

Qualification B.Pharma, B.Sc

Key Skills Study Design Patient Recruitment Good Clinical Practice Budget Management Clinical Monitoring Vendor Management Quality Control