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Clinical Trials Disclosure Mgr

Amgen
Amgen
2-4+ years
preferred by company
10 Feb. 6, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trials Disclosure Manager
Location: Hyderabad, India (On-site)
Job ID: R-234832
Category: Regulatory Affairs
Posted Date: January 29, 2026
Employment Type: Full-Time


Job Overview

A global biopharmaceutical organization is seeking a Clinical Trials Disclosure Manager to join its Regulatory Affairs team in Hyderabad. This role is responsible for leading clinical trial transparency and disclosure activities, ensuring compliance with global regulatory requirements for public disclosure of clinical trial data across US, EU, and international registries.

The role plays a critical part in protecting patient privacy and commercially confidential information while enabling accurate, timely, and compliant disclosure of clinical trial information.


Key Responsibilities

Clinical Trial Transparency and Disclosure

  • Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in accordance with global regulations, guidance, and internal policies.

  • Define and implement redaction strategies in collaboration with transparency and disclosure teams and cross-functional stakeholders.

  • Ensure accurate and timely registration, results posting, and document disclosure for US and EU registries, including ClinicalTrials.gov and EU CTR.

Cross-Functional Collaboration and Governance

  • Lead cross-functional review and approval processes for disclosure-ready documents and ensure submission readiness.

  • Coordinate handoff of approved materials for timely submission or public posting.

  • Serve as a key liaison between regulatory, clinical, legal, data privacy, and disclosure stakeholders.

Process Management and Continuous Improvement

  • Manage disclosure-related projects, coordinate work across teams, and prioritize activities to meet internal and external deadlines.

  • Support trend analysis, metrics tracking, and continuous improvement initiatives to enhance disclosure processes and quality.

  • Act as Process Administrator for Clinical Trial Registration Systems (CTRS), supporting system access, user inquiries, issue resolution, and active user management.


Required Skills and Competencies

  • Proven ability to interpret complex clinical and regulatory data and apply it in a practical disclosure context.

  • Hands-on experience with redaction and anonymization of clinical trial documents, including EU CTR and Health Canada PRCI requirements.

  • Experience managing disclosures on public registries such as ClinicalTrials.gov and EU CTR platforms.

  • Strong attention to detail, organizational skills, and ability to manage multiple priorities in a deadline-driven environment.

  • Excellent written and verbal communication skills in English.

  • Demonstrated leadership skills, including the ability to train, influence, negotiate, and collaborate with cross-functional teams.

  • Solid project management and problem-solving capabilities, with the ability to follow controlled and auditable processes.


Qualifications and Experience

  • Graduate degree with 2+ years of relevant experience in the pharmaceutical or biotechnology industry, or

  • Bachelor’s degree with 4+ years of relevant experience in the pharmaceutical or biotechnology industry.

  • Minimum 2 years of direct experience preparing regulatory documents for public clinical trial disclosure.

  • Strong familiarity with international regulations, guidance, and best practices related to clinical trial transparency, data privacy, and protection of commercially confidential information.


Equal Opportunity Statement

The organization is an Equal Opportunity Employer and is committed to providing a diverse and inclusive work environment. Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations are available throughout the recruitment process upon request.


Apply via thepharmadaily.com to advance your career in regulatory transparency and contribute to global clinical trial disclosure excellence.