About the Role
We are seeking a Medical Monitoring Implementation Lead / Clinical SME to serve as the clinical authority for our Patient Insights, medical-review dashboards, patient profiles, and advanced clinical analytics solutions.
In this role, you will bridge the gap between clinical decision-making and technology—ensuring that our digital health platforms are not only technically accurate, but also clinically meaningful, compliant, and optimized for Medical Monitors, Clinical Scientists, and Safety Physicians. You will own the clinical workstream end-to-end, partnering directly with sponsor study teams, Product, Data Science, and Engineering teams from scoping through clinical validation and deployment.
Key Responsibilities
Clinical Workstream Leadership: Own the clinical implementation lifecycle—from protocol interpretation and requirements discovery to dashboard design, clinical UAT, and end-user adoption.
Protocol & Data Review: Review clinical protocols, Statistical Analysis Plans (SAPs), CRFs, and data specifications to identify safety, efficacy, dosing, stopping rules,
and Adverse Events of Special Interest (AESI) review parameters.
Workflow & Visual Design: Translate complex study requirements into intuitive medical-monitoring workflows, patient profiles, listings, smart alerts, and aggregate visualizations tailored to Medical Monitor and Clinical Scientist personas.
Integrated Safety & Efficacy Monitoring: Support clinical review across AEs, SAEs, CTCAE grading, MedDRA coding, lab trends (e.g., Hy’s Law), vitals, ECGs, dose modifications, and patient disposition.
Disease-Response & Oncology Workflows: Apply oncology response frameworks (RECIST 1.1, iRECIST, nadir, sum-of-diameters, swimmer plots, best overall response) for solid tumors and hematologic malignancies.
Data Reconciliation & System Integrity: Reconcile data across EDC, safety databases, central labs, and imaging systems to isolate root causes of discrepancies (source data, derivations, or pr
📌 Medical Monitoring Implementation Lead (Chennai)
🏢 Saama
📍 Chennai