Project Manager Clinical Operations

Job Title: Senior Clinical Research Associate (Lead CRA) / Clinical Project Manager

Company: MS Clinical Research Pvt. Ltd.

Location: Bengaluru, India

About MS Clinical Research

MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing innovative therapies through high-quality clinical research. We partner with global sponsors and research sites to deliver clinical trials that meet the highest standards of scientific excellence, quality, and regulatory compliance.

Job Summary

MSCR is seeking a highly experienced Senior Clinical Research Associate (Lead CRA) / Clinical Project Manager with 10+ years of experience in clinical research and proven expertise in managing US-based clinical trials. The ideal candidate will have extensive monitoring and project oversight experience, strong knowledge of FDA regulations and ICH-GCP guidelines, and the ability to independently manage multiple clinical trial sites and stakeholder relationships.

Preference will be given to candidates who hold a valid US Visa and are willing to travel internationally as required.

Key Responsibilities

Clinical Trial & Site Oversight

• Independently manage and oversee clinical trial activities across multiple sites.
• Conduct and review Site Qualification, Initiation, Monitoring, and Close-Out Visits.
• Ensure compliance with study protocols, sponsor requirements, ICH-GCP, FDA regulations, and local regulatory requirements.
• Provide oversight for a minimum of 10 clinical trial sites across multiple studies.

US Clinical Trial Management

• Support and manage clinical studies involving US investigative sites and sponsors.
• Collaborate with US-based investigators, CROs, sponsors, and cross-functional teams.
• Ensure adherence to FDA regulations, 21 CFR requirements, and applicable international guidelines.
• Participate in sponsor meetings, study review meetings, and project governance discussions.

Monitoring & Quality Management

• Review monitoring reports and site performance metrics.
• Ensure timely resolution of monitoring findings, protocol deviations, and data queries.
• Oversee source data verification, essential documents, and Trial Master File quality.
• Support audit and inspection readiness activities.

Regulatory & Compliance

• Ensure compliance with ICH-GCP, FDA regulations, institutional requirements, and company SOPs.
• Review regulatory submissions, ethics committee documentation, and study-related communications.
• Maintain inspection-ready documentation throughout the study lifecycle.

Safety Management

• Ensure timely reporting and follow-up of Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Support investigators and study teams in meeting safety reporting requirements.

Leadership & Mentorship

• Mentor and guide CRAs and junior clinical operations team members.
• Provide operational leadership and contribute to process improvements.
• Serve as a subject matter expert for monitoring, site management, and compliance-related activities.

Sponsor & Stakeholder Management

• Act as a key point of contact for sponsors and study stakeholders.
• Present study updates, site performance metrics, risks, and mitigation plans.
• Foster strong relationships with investigators, site personnel, and sponsors.

Qualifications

Education

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline.

Experience

• Minimum 10 years of clinical research experience.
• Minimum 5 years of independent monitoring experience.
• Proven experience managing US-based clinical trials and/or US investigative sites.
• Experience handling at least 10 clinical trial sites independently.
• Prior experience in a Lead CRA, Senior CRA, Clinical Trial Manager, or Project Management role preferred.

Required Skills

• Strong knowledge of FDA regulations, ICH-GCP, and global clinical trial regulations.
• Experience working with US sponsors and international study teams.
• Excellent leadership, stakeholder management, and communication skills.
• Strong project planning, risk management, and problem-solving abilities.
• Ability to manage multiple studies and priorities effectively.

Preferred Qualifications

• Valid US Business/Tourist Visa (B1/B2) or eligibility to travel internationally.
• Experience supporting FDA inspections and regulatory audits.
• Exposure to global, multicenter clinical trials.
• Experience across multiple therapeutic areas.

Travel Requirements

• Willingness to travel domestically and internationally, including travel to the United States as required.

Benefits

• Competitive compensation package.
• International exposure and sponsor-facing opportunities.
• Leadership and career advancement opportunities.
• Collaborative and growth-oriented work environment.