Clinical Research Manager

Role Overview

Amura Health is building structured, condition-specific clinical service programs (Migraine, GERD, Gut Health, Mental Health, Metabolic Disorders, etc.) based on Natural Molecule Therapy (NMT) and chronic disease reversal models. We are seeking a highly analytical and research-driven Manager - Clinical Research to design, structure, and refine clinical study protocols and treatment frameworks aligned with evidence-based chronic care strategies.

This role sits at the intersection of: Clinical research design Evidence synthesis Protocol architecture Treatment framework optimization Data interpretation Regulatory compliance

You will work closely with the Chief Medical Officer and clinical leadership team to transform research insights into structured, scalable clinical intelligence systems.

Key Responsibilities:

Clinical Study Protocol Development ❖ Design, draft, and refine full clinical study protocols, including: Study objectives Primary and secondary endpoints Methodology and intervention models Safety monitoring plans Risk mitigation strategies ❖ Define inclusion and exclusion criteria ❖ Develop study flow architecture ❖ Design Case Report Forms (CRFs) ❖ Prepare informed consent documentation ❖ Maintain protocol version control and documentation standards

Treatment Framework Development ❖ Develop and optimize treatment frameworks aligned with chronic disease reversal models and NMT-based interventions ❖ Translate mechanistic biomedical research into structured intervention pathways Integrate: Clinical presentation Biomarkers Mechanistic pathways ❖ Create subtype classifications for chronic conditions ❖ Build structured escalation and pivot strategies within treatment models

Study Oversight & Lifecycle Management ❖ Oversee study lifecycle from concept to execution and closure ❖ Coordinate with operational and SOP teams for implementation ❖ Ensure adherence to ICH-GCP, CDSCO, and ICMR ethical guidelines ❖ Lead or support IRB/IEC submissions and amendments ❖ Maintain audit-ready documentation

Data Monitoring & Analysis Support ❖ Monitor data integrity throughout study execution ❖ Support statistical analysis using SPSS or equivalent tools ❖ Interpret study outputs in alignment with clinical objectives ❖ Identify trends, anomalies, and response patterns ❖ Translate data outcomes into structured clinical insights

Knowledge Structuring & Clinical Intelligence Systems ❖ Build structured documentation frameworks linking: Symptoms History patterns Investigations Mechanistic hypotheses Intervention logic Follow-up strategies ❖ Maintain citation-backed documentation ❖ Convert complex research findings into scalable clinical systems

Scientific Publication & Innovation ❖ Contribute to peer-reviewed publications and dissemination of clinical research findings. ❖ Identify and support patent filings related to proprietary treatment protocols and clinical innovations where applicable.

What we’re looking for: Master’s / PhD in Life Sciences, Clinical Research, Biotechnology, Medicine, or related field 7 to 12+ years of experience in clinical research and protocol development Demonstrated experience drafting full clinical study protocols Strong knowledge of clinical research methodology and documentation standards Familiarity with statistical tools (SPSS or equivalent) Deep understanding of biomedical literature interpretation

Required Skills & Competencies Strong clinical research and protocol design expertise High analytical and systems-thinking capability Strong documentation discipline and structured thinking Proficiency in spreadsheets and structured knowledge mapping Regulatory awareness (ICH-GCP, CDSCO, ICMR guidelines) Ability to synthesize complex scientific information into practical decision frameworks High attention to detail Strong cross-functional collaboration skills

Here are answers to some questions you may have

Where is your office? Chennai (Velachery)

Work Model Work from Office – because great stories are built in person!

Do you have an online presence? https://amura.ai (we are @AmuraHealth on all social media)

For better insights: https://drive.google.com/file/d/11UHgXqYc7XSJ3IAdFyEm-EurgOzqsmzA/view?usp=sharing