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 were looking for:

• Masters / 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