Medical monitor

JOB DESCRIPTION

Job Title: Medical Monitor

Department: Medical & Regulatory Affairs

Operating Unit: Translational and Clinical Research

Job Location: Bengaluru Karnataka

About Syngene: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

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 companys 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 integrityhealth 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 OversightMedical 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 IntegrityThey 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 GuidanceMedical monitors provide physician-level input during study design execution and reporting. Their expertise ensures that protocols are medically sound and feasible.
• Data Review & Quality AssuranceOngoing 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 ComplianceThey 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 Investigators Brochure informed Consent Document Investigators 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 toanticipate risksand guide adaptive trial designs.
• Provideclinical authorityin shaping protocols and safety-critical elements.
• Align medical monitoring with sponsor goals and regulatory expectations.

Decision-Making Under Pressure

• Rapid evaluation ofserious adverse events (SAEs)and emerging safety signals.
• Guideriskbenefit decisionsin collaboration with pharmacovigilance biostatistics and data teams.
• Ensure timely escalation of safety concerns to ethics committees and regulators.

Cross-Functional Collaboration

• Drivealignment across global teamsincluding investigators site staff data managers and statisticians.
• Act as themedical bridgebetween operational staff and scientific leadership.
• Support site teams with clear rapid medical answers to queries.

Communication & Influence

• Deliver complex medical insights inclear actionable languagefor non-medical stakeholders.
• Build trust with investigators sponsors and regulatory authorities.
• Influence protocol adherence and motivate teams to prioritize patient safety.

Operational Foresight

• Identifyprotocol deviations earlyand 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 withICH-GCP guidelinesand 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 toICH-GCP guidelinesand 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 KnowledgeDeep understanding of medicine pharmacology and therapeutic areas relevant to the trial.
• Safety AssessmentAbility to evaluate adverse events (AEs) and serious adverse events (SAEs) quickly and accurately.
• Regulatory KnowledgeFamiliarity with ICH-GCP FDA EMA and local regulatory requirements.
• Data InterpretationSkill in analysing clinical trial data spotting trends and identifying safety signals.
• CommunicationClear written and verbal communication with investigators sponsors and regulatory bodies.
• Problem-SolvingAbility to resolve protocol deviations site issues and safety concerns effectively.
• LeadershipGuiding 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.