Medical Monitor Job at Syngene | Apply Now
A medical monitor job is one of the most critical roles in clinical research, ensuring patient safety, scientific integrity, and regulatory compliance. If you are looking for Syngene careers, this opportunity for a Manager – Medical Monitor in Bengaluru offers a perfect blend of clinical expertise and research excellence. Ideal for professionals seeking an MBBS job or an MD Pharmacology job, this role provides exposure to global clinical trials and cutting-edge healthcare innovation.
Job Details
- Job Position: Manager – Medical Monitor
- Location: Bengaluru, Karnataka
- Department: Medical & Regulatory Affairs
About the Company
Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. This makes Syngene careers highly sought after among professionals looking for impactful roles in clinical research and healthcare innovation.
Job Description
This medical monitor job focuses on ensuring patient safety, maintaining scientific integrity, and providing expert medical guidance throughout clinical trials. It is an excellent opportunity for candidates pursuing an MBBS job or an MD Pharmacology job in clinical research.
Core Purpose of the Role
- Patient Safety Oversight: Medical monitors are licensed physicians who continuously evaluate participant well-being. They review adverse events, serious adverse events (SAEs), and unexpected reactions to ensure risks are managed appropriately.
- Scientific Integrity: They help maintain the credibility of the trial by ensuring that medical decisions and data interpretations are accurate, unbiased, and aligned with ethical standards.
- Expert Medical Guidance: Provide physician-level input during study design, execution, and reporting.
- Data Review & Quality Assurance: Identify trends, inconsistencies, or safety signals early, allowing corrective actions.
- Regulatory & Ethical Compliance: Ensure adherence to international guidelines (e.g., ICH-GCP), local regulations, and ethical standards.
Qualifications
- Education: MBBS, MD Pharmacology
Skills and Capabilities
- Clinical Knowledge in medicine and pharmacology
- Safety Assessment of AEs and SAEs
- Regulatory Knowledge (ICH-GCP, FDA, EMA)
- Data Interpretation and trend analysis
- Strong Communication skills
- Problem-Solving abilities
- Leadership and team guidance
Key Responsibilities
- Associate Research Physician in clinical trial related projects covering therapeutic areas, medical review, and interpretation of clinical and safety data.
- Support preparation and review of protocol-related documents such as Investigator’s Brochure, informed Consent Document, and Clinical Study Reports.
- Review MedDRA and WHO Drug Insight coding.
- Generate SAE narratives and perform quality review and analysis.
- Communicate SAE information to stakeholders as per guidelines and SOPs.
- Draft Integrated Summary of Safety and Efficacy for clinical trials.
- Review protocols and protocol synopsis for BA/BE and phase studies.
- Prepare Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS).
- Review Safety Management Plan (SMP).
- Prepare Site Feasibility Questionnaires (SFQs).
- Train study teams and address protocol-related queries.
- Manage regulatory documentation and timelines.
- Travel within India for site monitoring activities.
Leadership Capabilities
- Strategic oversight and adaptive trial design guidance
- Decision-making under pressure for SAEs and safety signals
- Cross-functional collaboration with global teams
- Clear communication of complex medical insights
- Operational foresight to detect protocol deviations
- Ethical and regulatory leadership ensuring compliance
