Clinical Research Manager - Full Time

Sunshine Manpower Solution And Services; Nagpur District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sunshine Manpower Solution And Services seeks a Senior Operations Manager - Clinical Research in Nagpur. The role oversees multi-study clinical operations, including start-up, activation, conduct, closeout and regulatory compliance.

You will lead Project Managers and CRCs while coordinating with PIs, sponsors, CROs and QA teams. Required are 6–10 years in clinical trials, strong ICH-GCP knowledge, and proficiency with CTMS/EDC/eTMF and MS Office.

Qualifications

• Bachelor's or Master's in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, Healthcare Management or related field.
• Proven clinical research operations and site management experience.
• Strong knowledge of ICH-GCP and regulatory compliance.
• Experience leading cross-functional teams and projects.
• Proficient in CTMS, EDC, eTMF and MS Office.

Responsibilities

• Manage clinical research operations across multiple studies/sites.
• Oversee 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.

Skills

Clinical ops

Site management

ICH-GCP

Team leadership

Stakeholder mgmt

CTMS

EDC

eTMF

MS Office

Education

Bachelor's/Master's in Life Sciences or related field

Tools

CTMS

EDC

eTMF

MS Office

Job description

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.

Qualification & 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.

Additional Information

• Experience

  6 - 10 Years

• No. of Openings

  2

• Education

  Graduate (B.Pharma, B.Sc)

• Role

  Clinical Research Manager

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  [ Male / Female ]

• Age Limit

  30 - 40 Yrs.

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office