Role & responsibilities

Site Management Operations
• Support site identification, feasibility assessments, qualification, initiation, maintenance, and close-out activities.
• Act as the primary point of contact for assigned investigators and research sites.
• Ensure timely collection and maintenance of essential regulatory and study documents.
• Coordinate site start-up activities and facilitate site readiness for study conduct.
• Monitor site performance, enrollment metrics, protocol compliance, trainings and operational quality.
• Support resolution of site-related operational challenges and protocol issues.

Medical & Scientific Oversight
• Provide medical and pharmacology expertise to investigators, study coordinators, and project teams.
• Review clinical protocols, investigator brochures, informed consent forms, and protocol amendments.
• Support patient eligibility assessments and protocol-specific medical reviews.
• Assist sites in interpretation of inclusion/exclusion criteria and protocol requirements.
• Review medical histories, concomitant medications, laboratory parameters, and safety data when required.
• Provide scientific support during investigator meetings, site initiation visits, and study training sessions.

Clinical Trial Management
• Support execution of Phase IIV clinical studies in compliance with protocol requirements.
• Track study timelines, recruitment targets, study milestones, and deliverables.
• Ensure adherence to ICH-GCP, NDCTR, CDSCO regulations, sponsor requirements, and SOPs.




• Support study monitoring activities and quality improvement initiatives.
• Assist with preparation for audits, inspections, and sponsor reviews.

Oncology Support
• Provide therapeutic expertise in oncology, including solid tumors, hematological malignancies, immunotherapy, and targeted therapies.
• Support oncology-specific patient screening and recruitment activities.
• Assist investigators in understanding protocol-defined oncology endpoints and treatment requirements.

Safety & Pharmacovigilance
• Review AEs, SAEs, and safety data for medical completeness.
• Support timely reporting and reconciliation of safety events.
• Assist in causality assessment and evaluation of medically significant events.
• Collaborate with Pharmacovigilance and Medical Monitoring teams.

Patient Recruitment & Retention
• Support sites in identification and recruitment of eligible patients.
• Monitor screening and enrollment performance.
• Analyze recruitment barriers and recommend improvements.

Regulatory & Compliance
• Support Ethics Committee and Regulatory Authority submissions.
• Maintain essential study documentation and TMF records.
• Ensure compliance with ICH-GCP, NDCTR, institutional policies, and sponsor requirements.

Preferred candidate profile

Educational Qualifications
• MD Pharmacology / MD Clinical Pharmacology

Experience
• 0 - 3 years in SMO, Clinical Research, Clinical Operations, Medical Monitoring Support, Pharmacovigilance, or Oncology Clinical Research.

📌 Site Management Operations (Ahmedabad)
🏢 Lambda Therapeutic Research
📍 Ahmedabad