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Manager, Informed Consent, Informed Consent Management

Bristol Myers Squibb
5+ years
Not Disclosed
Hyderabad
10 June 15, 2026
Job Description
Job Type: Full Time Education: Bachelor’s or Master’s degree in Technical , Life Sciences , Biology, Biochemistry, Molecular Biology Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

 

Manager – Informed Consent (IC) Operations

Company Overview

Bristol Myers Squibb (BMS) is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that transform patients' lives. The role is based at the BMS Hyderabad Global Hub, supporting global clinical development and innovation initiatives.


Position Summary

The Manager – Informed Consent (IC) Operations is responsible for managing informed consent processes across global clinical trials, ensuring compliance with regulatory requirements, patient safety standards, ethical guidelines, and BMS procedures. The role serves as a subject matter expert (SME) for informed consent documentation, language modifications, biospecimen consent management, and stakeholder collaboration.


Key Responsibility Areas

1. Informed Consent Management

Consent Document Oversight

  • Manage and oversee informed consent (IC) processes across clinical studies.
  • Review and process:
    • Informed Consent language modifications
    • Ethics Committee (EC) queries
    • Health Authority (HA) queries
    • Supporting patient-facing materials

Consent Language Management

  • Coordinate central triage of all:
    • Study-level language modifications
    • Country-level language modifications
    • Site-level language modifications
  • Track, assign, and monitor requests through completion.
  • Escalate complex issues to relevant stakeholders when required.

Template & Process Guidance

  • Guide BMS and CRO teams on:
    • Use of informed consent templates
    • Consent-related procedures
    • Regulatory requirements

2. Regulatory Compliance & Quality Assurance

Compliance Oversight

  • Ensure compliance with:
    • Good Clinical Practice (GCP)
    • Local regulations
    • Ethical requirements
    • Internal BMS SOPs

Audit & Inspection Support

  • Serve as subject matter expert during:
    • Regulatory inspections
    • Internal audits
    • External audits

Regulatory Liaison

  • Collaborate with Regional Country Operations to ensure adherence to country-specific laws and regulations.

3. Biospecimen & Data Consent Management

Consent Interpretation

  • Review consent documents to determine:
    • Permitted data usage
    • Biospecimen usage rights
    • Retention periods
    • Data sharing permissions

Biospecimen Governance

  • Support processes related to:
    • Clinical specimen management
    • Biobanking
    • Biorepositories
    • Biomarker research
    • Genetic research

Regulatory Support

  • Ensure collection, retention, and utilization of specimens and data align with patient consent.

Stakeholder Communication

  • Serve as a contact point for:
    • Health Authorities (HAs)
    • Institutional Review Boards (IRBs)
    • Ethics Committees (ECs)
  • Address questions related to:
    • Biomarker objectives
    • Biospecimen collection
    • Consent language

4. Cross-Functional Collaboration

Internal Stakeholders

Collaborate with:

  • Clinical Operations
  • Regulatory Affairs
  • Medical Affairs
  • Quality Teams
  • Regional Country Operations

External Stakeholders

Coordinate with:

  • CROs
  • Ethics Committees
  • Health Authorities
  • Investigators
  • Clinical Sites

Patient Safety & Data Integrity

  • Ensure patient safety considerations are incorporated into consent processes.
  • Maintain compliance related to specimen collection and data handling.

5. Issue Resolution & Process Improvement

Problem Solving

  • Identify and resolve complex consent-related issues.
  • Apply critical thinking and sound judgment to decision-making.

Continuous Improvement

  • Support optimization of informed consent processes.
  • Recommend improvements to increase compliance and operational efficiency.

Education Requirements

Required

  • Bachelor's Degree in:
    • Life Sciences
    • Biomedical Sciences
    • Pharmacy
    • Biotechnology
    • Other Scientific or Technical Discipline

Experience Requirements

Required

  • Minimum 5+ years of experience in:
    • Pharmaceutical Industry
    • Clinical Research
    • Clinical Drug Development
    • Scientific Research Environment

Required Specialized Experience

  • Direct experience working with:
    • Informed Consent Documents
    • Clinical Trial Operations

Preferred

  • Clinical Specimen Management
  • Biobanking / Biorepositories
  • Biomarker Research
  • Genetics Research

Technical Competencies

Clinical Research Knowledge

  • Clinical Trial Operations
  • Informed Consent Processes
  • Clinical Development Lifecycle
  • Patient Safety Standards

Regulatory Knowledge

  • Good Clinical Practice (GCP)
  • Ethics Committee Requirements
  • Health Authority Requirements
  • Clinical Trial Regulations

Biospecimen Management

  • Biospecimen Governance
  • Sample Retention Requirements
  • Biomarker Studies
  • Genetic Research Compliance

Technology & Systems

Proficiency in:

  • Microsoft Teams
  • Microsoft Office 365
  • Labmatrix
  • Consent Tracking Platforms
  • Clinical Trial Management Systems (CTMS)
  • Electronic Trial Master File (eTMF)

Core Competencies

Functional Competencies

  • Informed Consent Management
  • Regulatory Compliance
  • Clinical Operations Support
  • Consent Language Review
  • Biospecimen Compliance

Analytical Competencies

  • Critical Thinking
  • Problem Solving
  • Decision Making
  • Risk Assessment

Communication Competencies

  • Written Communication
  • Verbal Communication
  • Presentation Skills
  • Stakeholder Engagement

Organizational Competencies

  • Project Management
  • Prioritization
  • Multi-tasking
  • Time Management

Interpersonal Competencies

  • Collaboration
  • Cross-functional Teamwork
  • Relationship Management
  • Influencing Skills

Work Environment

Work Location

  • BMS Hyderabad Global Capability Center

Travel Requirements

  • Minimal travel required
  • Less than 5% domestic travel

Work Model

Depending on assignment:

  • Site-Essential (100% Onsite)
  • Site-by-Design (Hybrid)
  • Field-Based
  • Remote-by-Design

Ideal Candidate Profile

A clinical research professional with strong expertise in informed consent management, regulatory compliance, and clinical trial operations who can independently manage global consent processes, collaborate across complex matrix organizations, ensure patient safety and data integrity, and serve as a subject matter expert for informed consent and biospecimen governance