Medical monitor

Date: 12 Dec 2025

Location:

IN

Division: Discovery Services

Job Description

Job Title: Medical Monitor

Department: Medical & Regulatory Affairs

Operating Unit: Translational and Clinical Research

Job Location: Bengaluru, Karnataka

About Syngene: Syngene (www.syngeneintl.com) 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

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensure safe operations and compliance with the company's integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time
  
  

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.
  
  

Role Accountabilities

• 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.
  
  

Leadership Capabilities

Strategic Oversight

• Ability to anticipate risks and guide adaptive trial designs.
• Provide clinical authority in shaping protocols and safety-critical elements.
• Align medical monitoring with sponsor goals and regulatory expectations.
  
  

Decision-Making Under Pressure

• Rapid evaluation of serious adverse events (SAEs) and emerging safety signals.
• Guide riskbenefit decisions in collaboration with pharmacovigilance, biostatistics, and data teams.
• Ensure timely escalation of safety concerns to ethics committees and regulators.
  
  

Cross-Functional Collaboration

• Drive alignment across global teams including investigators, site staff, data managers, and statisticians.
• Act as the medical bridge between operational staff and scientific leadership.
• Support site teams with clear, rapid medical answers to queries.
  
  

Communication & Influence

• Deliver complex medical insights in clear, actionable language for non-medical stakeholders.
• Build trust with investigators, sponsors, and regulatory authorities.
• Influence protocol adherence and motivate teams to prioritize patient safety.
  
  

Operational Foresight

• Identify protocol deviations early and implement corrective actions.
• Use real-time data streams and monitoring tools to track safety trends.
• Balance efficiency with thoroughness to keep trials on schedule without compromising integrity.
  
  

Ethical & Regulatory Leadership

• Ensure compliance with ICH-GCP guidelines and local regulations.
• Uphold ethical standards, keeping participant welfare at the forefront.
• Lead by example in maintaining transparency and accountability.
  
  

Syngene Values: All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism
  
  

Specific Requirements For This Role

Education: MBBS MD Pharmacology

Experience: Foundational

Demonstrated Capability

Clinical Expertise: Apply deep medical knowledge to interpret complex patient data. Identify and evaluate adverse events (AEs) and serious adverse events (SAEs). Provide clear medical guidance to investigators on patient management.

Safety Oversight: Monitor ongoing safety signals across sites and populations. Make timely decisions on riskbenefit balance. Escalate concerns to ethics committees, sponsors, and regulators when necessary.

Regulatory & Ethical Compliance: Ensure adherence to ICH-GCP guidelines and local regulatory requirements. Uphold ethical standards, keeping participant welfare as the top priority. Demonstrate transparency in documentation and reporting.

Leadership & Collaboration: Lead cross-functional discussions with investigators, CRAs, data managers, and statisticians. Mentor junior staff and provide medical training to site teams. Resolve conflicts between operational and medical priorities.

Analytical & Decision-Making Skills: Review large datasets to detect trends in efficacy and safety. Interpret clinical data to support interim analyses and final study reports. Make evidence-based recommendations for protocol amendments.

Communication Excellence: Translate complex medical findings into clear, actionable insights for non-medical stakeholders. Provide rapid, accurate responses to site queries. Build trust with sponsors, investigators, and regulatory authorities.

Skills And Capabilities

• Clinical Knowledge Deep understanding of medicine, pharmacology, and therapeutic areas relevant to the trial.
• Safety Assessment Ability to evaluate adverse events (AEs) and serious adverse events (SAEs) quickly and accurately.
• Regulatory Knowledge Familiarity with ICH-GCP, FDA, EMA, and local regulatory requirements.
• Data Interpretation Skill in analysing clinical trial data, spotting trends, and identifying safety signals.
• Communication Clear written and verbal communication with investigators, sponsors, and regulatory bodies.
• Problem-Solving Ability to resolve protocol deviations, site issues, and safety concerns effectively.
• Leadership Guiding cross-functional teams and mentoring junior staff.
  
  

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.