Clinical Trial Manager

Job Title: Senior Clinical Research Associate / Clinical Trial Manager Clinical Operations

Location: Mumbai – BKC
Experience: 7–10 Years
Function: Clinical Operations / Clinical Research
Employment Type: Full-Time
Travel: Approximately 60%

Job Summary

We are looking for an experienced clinical research professional with strong hands-on onsite monitoring and site management experience to support clinical trial operations. The ideal candidate will have a strong CRA background along with exposure to Clinical Trial Management / Project Management, preferably within a global CRO or pharmaceutical organization.

Key Responsibilities

• Manage clinical trial sites from site identification, feasibility and site assessment through site initiation, monitoring and close-out.
• Conduct and oversee onsite monitoring activities in accordance with protocols, SOPs, ICH-GCP and applicable regulatory requirements.
• Maintain effective communication with investigators, site teams, study teams and other stakeholders.
• Support site activation, recruitment, data quality, issue resolution and overall site performance.
• Identify and manage site-level risks, deviations and operational challenges.
• Contribute to clinical trial/project management activities including timelines, tracking, documentation and cross-functional coordination.
• Provide guidance and support to CRAs and other clinical operations team members where required.
• Participate in investigator/site meetings and support study-related presentations.
• Ensure accurate and timely completion of study documentation and essential documents.
• Support regulatory and quality requirements throughout the study lifecycle.
• Travel extensively to clinical trial sites as required.

Required Skills & Experience

• 7–10 years of relevant experience in Clinical Research / Clinical Operations.
• Strong hands-on onsite monitoring experience, preferably 8+ years.
• Experience as CRA / Senior CRA / Lead CRA / Principal CRA.
• Minimum 1–2 years of Clinical Trial Management / Project Management exposure.
• Strong experience in complete site management from pre-trial/site assessment through close-out.
• Good understanding of ICH-GCP, clinical trial processes and regulatory requirements.
• Experience working with global MNC Pharma or CRO organizations is preferred.
• Strong stakeholder management, communication and problem-solving skills.
• Willingness to travel extensively as part of the role.
• Oncology experience is preferred.

Preferred Educational Background

• BSc/MSc in Clinical Research, Life Sciences, Biotechnology, Molecular Biology, Microbiology, Biochemistry or related disciplines.
• B.Pharm / M.Pharm or equivalent relevant qualifications may also be considered.

Preferred Candidate Profile

Candidates currently working in onsite clinical monitoring / CRA / Senior CRA / Lead CRA / Principal CRA / Clinical Trial Management roles are preferred. Candidates whose experience has shifted predominantly to centralized monitoring may not be suitable, as this position requires strong hands-on site engagement and onsite monitoring experience.