Medical Job – Manager Medical Monitor Role at Syngene in Bangalore
Looking for a rewarding Medical job? This Manager – Medical Monitor role at Syngene offers an excellent opportunity for professionals seeking an MBBS Job or MD Pharmacology job in a leading innovation-led organization. Based in Bengaluru, this position plays a crucial role in patient safety oversight, regulatory compliance, and scientific integrity within clinical trials.
Job Details:
- Job Title: Manager – Medical Monitor
- Job Location: Bengaluru, Karnataka
- Department: Medical & Regulatory Affairs
- Division: Discovery Services
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 done personally and professionally. Safety is placed at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.
Job Description
This Medical job for Manager – Medical Monitor at Syngene involves overseeing patient safety, reviewing clinical and safety data, evaluating adverse events (AEs) and serious adverse events (SAEs), and ensuring compliance with ICH-GCP and regulatory standards. The role provides expert medical guidance during study design, execution, and reporting, making it a strong opportunity for candidates seeking an MBBS Job or MD Pharmacology job and a medical job in Bangalore within clinical research.
Qualifications:
- Education: MBBS, MD Pharmacology
- Experience: Foundational
Demonstrated Capability:
- Clinical Expertise in interpreting patient data and evaluating AEs and SAEs.
- Safety Oversight across sites and populations.
- Regulatory & Ethical Compliance with ICH-GCP and local requirements.
- Leadership & Collaboration with investigators, CRAs, data managers, and statisticians.
- Analytical & Decision-Making Skills in reviewing datasets and supporting study reports.
- Communication Excellence in delivering actionable medical insights.
Skills and Capabilities:
- Clinical Knowledge of medicine, pharmacology, and therapeutic areas.
- Safety Assessment of AEs and SAEs.
- Regulatory Knowledge including ICH-GCP, FDA, EMA, and local regulations.
- Data Interpretation skills to identify safety signals.
- Communication with investigators, sponsors, and regulatory bodies.
- Problem-Solving and Leadership abilities.
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: Medical monitors provide physician-level input during study design, execution, and reporting. Their expertise ensures that protocols are medically sound and feasible.
- Data Review & Quality Assurance: Ongoing review of trial data by medical monitors enhances the quality of research. They identify trends, inconsistencies, or safety signals early, allowing corrective actions.
- Regulatory & Ethical Compliance: They ensure that the trial adheres to international guidelines (e.g., ICH-GCP), local regulations, and ethical standards, protecting both participants and the credibility of the sponsor.
Key Responsibilities:
- Associate Research Physician in clinical trial related projects covers various therapeutic areas, medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation and in accordance with applicable regulatory and SOP requirements.
- Support in the preparation and review of protocol related appendices like Investigator’s Brochure, informed Consent Document, Investigator’s Undertaking, and any other documents related to protocol and CSR.
- Review of the MedDRA and WHO Drug Insight coding as and when required for the projects.
- Support the Senior Research Physician in generating SAE narratives and performing quality review and analysis of similar events.
- Communication of the SAE to all stakeholders as per the format and timelines indicated in the guidelines and internal SOP and keep a track of the same when required for clinical trials.
- Take a lead role in drafting the Integrated Summary of Safety and Efficacy for all clinical trial projects where in he/she is designated the responsibility.
- Review of protocol and protocol synopsis for BA/BE and phase studies in collaboration with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitor.
- Preparation of Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS), if applicable.
- Review of the SMP (Safety Management plan), if in scope of work.
- Preparation of SFQs (Site Feasibility Questionnaires) and summary for patient-based studies.
- Training the required study team members and addressing protocol related queries in a timely manner.
- Provide input regarding deliverables with accurate timelines and processes and support completion of quality regulatory documents.
- Managing documents with multiple review cycles and deadlines.
- Will be required to travel within India to study sites to perform site monitoring activities as per the scope of the project.
