Pursue Clinical Research Excellence as a Medical Monitor
Drive Scientific Rigor and Patient Safety with a Global Leader
Lambda Therapeutic Research is a distinguished global Clinical Research Organization (CRO) at the forefront of drug development. With our headquarters in Ahmedabad and a strategic international network, we provide comprehensive, end-to-end clinical research services. We are seeking a dedicated Medical Monitor to ensure the scientific integrity and ethical conduct of our clinical trials, serving as a critical liaison between science, safety, and operations.
Key Responsibilities
Protocol & Feasibility Leadership
- Conduct medical and scientific feasibility assessments for proposed study molecules and protocols.
- Critically review clinical study protocols to ensure scientific validity, patient safety, and operational practicality.
- Act as an Investigator, ensuring all protocol requirements are met during participant screening and study conduct.
Study Oversight & Compliance
- Coordinate and supervise the study team to ensure strict adherence to the protocol, SOPs, and all regulatory requirements (ICH-GCP, local regulations).
- Serve as the primary medical point of contact for sponsors, addressing all medical and scientific inquiries.
- Liaise with the Independent Ethics Committee (IEC) and local regulatory authorities, communicating study updates, amendments, and concerns.
Safety & Pharmacovigilance Management
- Take medical responsibility for monitoring and managing all Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Lead the medical review and assessment of safety-related issues, coordinating with the study team for appropriate management and documentation.
- Ensure timely and accurate medical input for safety reports.
Scientific Development & Quality Systems
- Contribute to the scientific development of the organization through medical insights and continuous improvement initiatives.
- Maintain, update, and develop department-specific systems, SOPs, and medical monitoring plans.
Qualifications & Experience
Essential Requirements:
- MD in Pharmacology from a recognized institution.
- 2 to 3 years of direct experience in a medical monitoring, clinical research, or pharmacovigilance role within a CRO, pharmaceutical, or biotech company.
- In-depth knowledge of ICH-GCP guidelines, clinical trial methodology, and regulatory requirements.
- Proven experience in protocol review, safety management (AE/SAE handling), and medical oversight.
- Excellent communication skills for effective interaction with sponsors, IEC, regulatory bodies, and internal cross-functional teams.
- Strong analytical, decision-making, and problem-solving abilities.
Preferred Attributes:
- Previous experience in a client-facing role as a Medical Monitor for a CRO.
- Exposure to multiple therapeutic areas.
- Familiarity with electronic data capture (EDC) systems and clinical trial management software.
Why Build Your Career at Lambda?
- Strategic Medical Impact: Play a central role in protecting patient safety and ensuring data integrity across global clinical trials.
- Professional Growth: Accelerate your career within medical affairs and clinical development in a dynamic, global CRO environment.
- Global Collaboration: Work directly with international sponsors and experts, building a valuable professional network.
- Scientific Leadership: Contribute to the scientific framework and quality systems of a growing organization.
- End-to-End Exposure: Gain comprehensive insight into the entire clinical trial lifecycle.
Ready to apply your medical expertise to advance global clinical research?
Apply now for the Medical Monitor position at Lambda Therapeutic Research.
Lambda Therapeutic Research is an equal opportunity employer. We are committed to creating an inclusive environment and value the diverse backgrounds and perspectives our team members bring to pioneering medical research.
