Site Management Operations

About the Role

Lambda Therapeutic Research is seeking a Site Management Operations professional to support clinical site activities, medical review, and trial execution across assigned studies. The position is based in Ahmedabad and requires close coordination with investigators, research sites, and internal study teams to keep operations running smoothly and in compliance with applicable standards.

Site Management Operations

• Assist with identifying study sites, carrying out feasibility reviews, qualifying sites, helping with initiation, supporting ongoing maintenance, and completing close-out activities.
• Serve as the main contact for the investigators and research sites allocated to you.
• Make sure essential regulatory and study documents are collected on time and kept up to date.
• Coordinate start-up tasks and help prepare sites so they are ready for study conduct.
• Track site performance, enrollment progress, protocol adherence, training completion, and overall operational quality.
• Help resolve operational issues and protocol-related challenges at the site level.

Medical & Scientific Oversight

• Apply medical and pharmacology knowledge while supporting investigators, coordinators, and project teams.
• Review clinical protocols, investigator brochures, informed consent forms, and any protocol amendments.
• Support assessment of patient eligibility and medically relevant protocol reviews.
• Help sites interpret inclusion and exclusion criteria as well as protocol-specific instructions.
• Review medical histories, concomitant medications, laboratory values, and safety data whenever needed.
• Provide scientific input during investigator meetings, site initiation visits, and training sessions.

Clinical Trial Management

• Contribute to the conduct of Phase IIV clinical studies in line with protocol expectations.
• Monitor study timelines, recruitment goals, key milestones, and deliverables.
• Ensure work is aligned with ICH-GCP, NDCTR, CDSCO regulations, sponsor expectations, and SOPs.
• Support monitoring-related activities and continuous quality improvement efforts.
• Assist in preparing for audits, inspections, and sponsor review activities.

Oncology Support

• Provide subject-matter support in oncology, including solid tumors, hematological malignancies, immunotherapy, and targeted therapies.
• Assist with oncology patient screening and enrollment efforts.
• Help investigators understand protocol-defined oncology endpoints and treatment-related requirements.

Safety & Pharmacovigilance

• Review adverse events, serious adverse events, and other safety information to ensure medical completeness.
• Support timely safety reporting and reconciliation of event data.
• Assist with causality evaluation and review of medically significant events.
• Work alongside pharmacovigilance and medical monitoring teams as needed.

Patient Recruitment & Retention

• Support sites in finding and enrolling eligible patients.
• Track screening outcomes and enrollment trends.
• Identify barriers to recruitment and suggest practical improvements.

Regulatory & Compliance

• Support submissions to Ethics Committees and Regulatory Authorities.
• Maintain essential study records and Trial Master File documentation.
• Ensure ongoing compliance with ICH-GCP, NDCTR, institutional policies, and sponsor requirements.

Educational Qualification

The preferred qualification for this role is MD Pharmacology or MD Clinical Pharmacology.

Experience

Applicants should bring 23 years of experience in SMO, Clinical Research, Clinical Operations, Medical Monitoring Support, Pharmacovigilance, or Oncology Clinical Research.