Manager – Informed Consent, Informed Consent Management
Job ID: R1603157
Company: Bristol Myers Squibb
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Function: Clinical Trial Operations / Informed Consent Management
Position Summary
The Manager – Informed Consent is responsible for overseeing end-to-end management of informed consent documentation across clinical trials. The role ensures compliance with global and local regulatory requirements, Good Clinical Practice (GCP), and BMS SOPs while coordinating cross-functional stakeholders to maintain ethical and compliant patient consent processes.
Key Responsibilities
Informed Consent Document Management
Act as central triage for all study, country, and site-level informed consent (IC) language modifications.
Review and process consent document updates in accordance with BMS SOPs.
Track and assign requests for consent changes and related queries from ethics committees and health authorities.
Manage escalation of complex consent-related issues to relevant stakeholders.
Cross-Functional Coordination
Collaborate with Clinical Operations, Regulatory, Ethics Committees (ECs), Institutional Review Boards (IRBs), and Country Operations teams.
Ensure alignment of informed consent templates and language across global studies.
Liaise with regional teams to ensure compliance with local laws and regulatory requirements.
Guide BMS and CRO teams on proper use of consent templates and materials.
Compliance & Quality Assurance
Ensure adherence to Good Clinical Practice (GCP) guidelines.
Support audit and inspection readiness related to informed consent documentation.
Identify and resolve complex consent compliance issues.
Ensure patient safety, data integrity, and specimen compliance in consent processes.
Subject Matter Expertise
Serve as subject matter expert (SME) in informed consent management.
Provide guidance on consent interpretation, including:
Data and biospecimen use
Retention periods
Genetic and biomarker research consent elements
Support regulatory interactions involving consent language and biospecimen-related queries.
Negotiate or support consent language discussions with Health Authorities (HAs), IRBs, and ECs when required.
Process Management & Operations
Manage multiple concurrent consent-related requests and ensure timely resolution.
Prioritize and organize complex workflows in a fast-paced environment.
Support use of consent tracking platforms and clinical systems.
Ensure proper documentation within systems such as CTMS and eTMF.
Stakeholder Support & Issue Resolution
Provide guidance to internal teams and CRO partners on consent-related matters.
Resolve complex consent issues using critical thinking and regulatory understanding.
Support study teams during trial execution with consent-related expertise.
Optional Extended Responsibilities (Subset of Role)
Interpret consent language related to biospecimen and data usage.
Act as SME for biomarker and genetic consent frameworks.
Engage with Health Authorities/IRBs for consent-related discussions.
Ensure alignment of specimen/data use with participant consent agreements.
Minimum Requirements
Education
Bachelor’s degree in a scientific or technical discipline.
Experience
5+ years of experience in:
Clinical trial operations, OR
Pharmaceutical/biopharma clinical development
Direct experience working with informed consent documents required.
Preferred Experience
Clinical specimen management or biobanking
Biomarker or genetic research exposure
Clinical trial systems (CTMS, eTMF)
Consent tracking platforms (e.g., Labmatrix)
Required Skills & Competencies
Technical Knowledge
Informed Consent Management
Good Clinical Practice (GCP)
Clinical Trial Operations
Regulatory & Ethics Committee processes
Biospecimen and data governance (preferred)
Operational Skills
Multi-tasking in complex environments
Workflow and escalation management
Risk identification and issue resolution
Documentation and compliance tracking
Communication & Collaboration
Strong written and verbal communication
Stakeholder management across global teams
Cross-functional coordination in matrix organizations
Digital & System Skills
Microsoft Office 365
Microsoft Teams
CTMS / eTMF systems
Consent tracking tools (e.g., Labmatrix or similar platforms)
Ideal Candidate Profile
Experienced clinical operations professional with strong expertise in informed consent processes.
Comfortable managing complex regulatory and ethics-driven documentation workflows.
Strong understanding of global clinical trial compliance frameworks.
Detail-oriented, process-driven, and able to handle high-volume, time-sensitive tasks.
Effective communicator capable of coordinating across global stakeholders.
Career Focus Areas
Clinical Trial Operations
Regulatory Compliance (GCP)
Informed Consent & Ethics Management
Clinical Documentation Governance
Biospecimen & Data Compliance
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