Are you an experienced clinical research professional ready to take on a leadership role in managing trials and regulatory processes? Samahitha Research is hiring a Project Manager in Clinical Operations to join its growing team in Bengaluru, Karnataka. If you have over 3 years of experience in clinical research and a passion for driving excellence in trial management, this could be the perfect opportunity for you.
🧠 About the Role
As a Project Manager – Clinical Operations, you will be responsible for overseeing the planning, execution, and documentation of clinical trials. You’ll work closely with sponsors, investigator sites, subcontractors, and internal teams to ensure that trials are conducted efficiently, ethically, and in compliance with regulatory standards.
This role demands strong organisational skills, attention to detail, and the ability to manage multiple stakeholders across various phases of clinical research.
📍 Job Location
Bengaluru, Karnataka
Employment Type: Full-time
Experience Required: Minimum 3 years in Clinical Research
Industry: Life Sciences, Clinical Trials, Regulatory Affairs
📋 Key Responsibilities
Your day-to-day responsibilities will include:
🔐 Maintaining confidentiality of proprietary information from sponsors, investigator sites, and third-party vendors.
📦 Managing subcontractor activities such as clinical laboratories, translation agencies, and printing vendors.
📝 Developing and customising study documents, including monitoring plans, informed consent forms, IMP labels, and trial-specific guidelines.
🌐 Overseeing translation processes and regulatory submissions for assigned trials.
📁 Compiling and verifying submission packages for accuracy and completeness.
🧑🏫 Planning and representing Samahitha at investigator meetings.
⚠️ Handling adverse event reporting during clinical trials.
💊 Managing clinical trial supplies, including drug accountability and storage coordination.
🗂️ Maintaining the Trial Master File with all study-related documentation.
🧭 Coordinating site initiation, monitoring, and closure visits.
👥 Supporting and guiding CRAs and CTAs involved in the trial.
📊 Generating and managing study databases and progress documentation.- 🔄 Managing data clarification flow and conducting co-monitoring visits.
📣 Updating investigators and team members through newsletters and calls.
🎓 Qualifications
To be considered for this role, candidates must meet the following criteria:
✅ Minimum 3 years of experience in clinical research operations.
✅ Strong understanding of regulatory requirements and trial documentation.
✅ Proven ability to manage cross-functional teams and external vendors.
✅ Excellent communication, planning, and organisational skills.
✅ Experience in managing Trial Master Files and clinical trial supplies.
🌟 Why Join Samahitha Research?
Samahitha Research is a trusted name in clinical trial management, known for its commitment to quality, compliance, and innovation. By joining the team, you’ll gain:
🌐 Exposure to global clinical research standards
📈 Opportunities for career advancement in regulatory and clinical operations
🤝 A collaborative work environment that values integrity and transparency
🧪 Hands-on experience with diverse clinical trial phases and therapeutic areas
📩 How to Apply
If you meet the qualifications and are ready to take the next step in your clinical research career, we invite you to apply.
📧 Send your resume to:
👉 career@samahitha.com
Please include “Project Manager – Clinical Operations” in the subject line of your email.