Saama
Website:
saama.com
Job details:
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 precise, 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 product logic).
- Clinical Validation & Risk-Based UAT: Lead UAT for dashboards, patient profiles, and AI-generated outputs. Construct clinical edge cases (conflicting dates, partial dosing, unscheduled visits) and govern risk-based clinical sign-offs.
- Clinician-to-Engineer Translation: Facilitate clinician-to-clinician discovery sessions, converting feedback into structured user stories, acceptance criteria, and engineering requirements.
- AI & Analytics Governance: Validate AI-generated narratives, summaries, and recommendations for clinical relevance, source grounding, explainability, and hallucination risk, enforcing human-in-the-loop controls.
Qualifications
Required:
- Education: Medical degree (MD, DO, MBBS, or equivalent clinical qualification).
- Experience: 10+ years in pharma, biotech, CRO, or clinical technology environments, with significant direct experience in medical monitoring, clinical development, or safety review.
- Domain Knowledge: Expertise in AE/SAE/AESI review, CTCAE grading, MedDRA coding, lab trends, exposure, and patient-level benefit-risk analysis.
- Protocol Analysis: Demonstrated ability to interpret protocols, SAPs, CRFs, TFLs, IBs, and Clinical Study Reports (CSRs).
- Clinical Systems: Working knowledge of clinical trial data streams (EDC, central lab, safety databases, eCOA, imaging, CDISC/SDTM).
- Validation & Compliance: Hands-on experience executing clinical UAT and working under ICH-GCP, GxP, and data integrity standards.
- Communication: Exceptional clinician-facing presentation, stakeholder management, and medical-writing skills.
Strongly Preferred:
- Medical-monitoring experience in oncology (solid tumors and/or hematologic malignancies) and practical application of RECIST 1.1 / iRECIST.
- Formal medical-writing experience (safety narratives, CSRs, Investigator Brochures).
- Early-phase trial experience, real-time safety review, or Safety Review Committee (SRC) support.
- Experience evaluating or implementing AI-enabled clinical review and summarization tools.
- Prior client-facing consulting or software implementation experience.
Why Join Us?
- Drive the adoption of next-generation, AI-enabled clinical trial technologies.
- Work at the intersection of clinical medicine, data science, and enterprise software.
- Collaborate directly with executive medical leadership at leading global pharmaceutical organizations.
Click on Apply to know more.
