Samahitha is a leading clinical research organization (CRO) specializing in end-to-end clinical trial management. With a strong focus on compliance, quality, and innovation, Samahitha partners with global pharmaceutical and biotech companies to deliver efficient clinical research solutions.
Job Title: Project Manager – Clinical Operations
Location: Bengaluru, Karnataka
Experience: 3+ years in Clinical Research
Employment Type: Full-time
Key Responsibilities:
- Maintain confidentiality of proprietary information related to Sponsors, Investigator Sites & Third Parties.
- Oversee subcontractor activities (labs, translation agencies, CRF printing, etc.).
- Develop and customize study documents (Informed Consent, IMP Labels, Monitoring Plans).
- Manage regulatory submissions and ensure compliance.
- Plan and represent Samahitha at investigator meetings.
- Handle adverse event reporting and clinical trial supplies management.
- Maintain Trial Master Files (TMF) and oversee monitoring visits (initiation, routine, closure).
- Coordinate with CRAs & CTAs, track enrollment, and manage data clarification flow.
- Conduct co-monitoring visits and update stakeholders.
Eligibility Criteria:
- Bachelor’s/Master’s degree in Life Sciences, Pharmacy, or related field.
- 3+ years in clinical research operations, preferably in a CRO or pharma company.
- Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial management.
- Excellent project management, communication, and leadership skills.
Benefits:
- Competitive salary & performance incentives.
- Opportunity to work on global clinical trials.
- Career growth in a dynamic clinical research environment.
How to Apply:
Interested candidates can email their resume to career@samahitha.com with the subject line: “Application for Project Manager – Clinical Operations”.
