Clinical Research Job: Project Manager Role at Samahitha

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”.