Medical Monitor – Bengaluru, India | Translational & Clinical Research
Industry: Clinical Research / Discovery Services | Location: Bengaluru, Karnataka, India
Syngene International Ltd. is seeking a Medical Monitor to join our Translational and Clinical Research team in Bengaluru. This role provides physician-level oversight for clinical trials, ensuring patient safety, data integrity, and compliance with regulatory and ethical standards. The position involves cross-functional collaboration, medical guidance during study design, and continuous monitoring of safety and efficacy outcomes across clinical studies.
About Syngene
Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization (CRDMO) offering integrated scientific services from early discovery to commercial supply. Safety, scientific integrity, and excellence drive everything we do, ensuring both operational discipline and patient-focused outcomes in all clinical and research activities.
Core Responsibilities
Patient Safety Oversight
Monitor ongoing clinical trials and evaluate participant well-being.
Review adverse events (AEs) and serious adverse events (SAEs), identifying safety signals and managing risks.
Provide clear guidance to investigators for timely patient management.
Scientific & Clinical Integrity
Ensure medical decisions and data interpretations are accurate, unbiased, and aligned with trial protocols.
Support the preparation and review of protocol-related documents including Investigator’s Brochure, Informed Consent Documents, and Clinical Study Reports.
Review MedDRA and WHO Drug Insight coding as required.
Data Review & Quality Assurance
Perform detailed medical review and analysis of clinical and safety data.
Draft Integrated Summary of Safety and Efficacy reports for assigned clinical trials.
Collaborate with biostatisticians, CRAs, bioanalytical teams, and regulatory personnel to ensure high-quality trial data.
Regulatory & Ethical Compliance
Ensure adherence to ICH-GCP guidelines, local regulations, and ethical standards.
Prepare Medical Monitoring Plans (MMPs), Risk Evaluation and Mitigation Strategies (REMS), Safety Management Plans (SMPs), and site feasibility assessments.
Maintain transparency and accountability in reporting and documentation.
Leadership & Collaboration
Mentor and train junior staff and site teams.
Serve as the medical bridge between investigators, operational staff, and senior leadership.
Lead cross-functional discussions, resolve protocol deviations, and implement corrective actions.
Operational Excellence
Travel to study sites within India as required.
Ensure timely and accurate communication of safety concerns to ethics committees, sponsors, and regulatory authorities.
Monitor data trends and provide actionable insights for interim analyses and final study outcomes.
Qualifications & Experience
Education: MBBS or MD in Pharmacology.
Experience: Foundational to mid-level experience in clinical trials, pharmacovigilance, or medical monitoring roles.
Demonstrated expertise in adverse event evaluation, clinical trial safety oversight, and regulatory compliance.
Strong analytical, problem-solving, and decision-making skills with ability to review large clinical datasets.
Excellent written and verbal communication skills to convey complex medical insights to stakeholders.
Skills & Competencies
Deep understanding of medicine, pharmacology, and therapeutic areas relevant to clinical trials.
Ability to evaluate and interpret AEs and SAEs accurately.
Familiarity with ICH-GCP, FDA, EMA, and local regulatory requirements.
Strong cross-functional leadership and mentorship skills.
Problem-solving capabilities to address protocol deviations and site-level issues.
Commitment to patient safety, ethical practices, and data integrity.
Syngene Values
All employees are expected to demonstrate alignment with core values:
Excellence
Integrity
Professionalism
Equal Opportunity Employer: Syngene is committed to providing equal employment opportunities to all individuals and reasonable accommodations for qualified persons with disabilities, in compliance with applicable laws and regulations.
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