Clinical Trials Disclosure Manager

11 hours ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Roles & Responsibilities:

  • Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
  • Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
  • Support trend analysis and continuous improvement initiatives
  • Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines

Required Skills:

  • Experience understanding and interpreting data/information and its practical application
  • Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
  • Working experience with disclosures on public registries e.g.
  • Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
  • Good communication skills including excellent spoken and written English
  • Ability to follow controlled processes
  • Leadership skills, including ability to teach, negotiate and influence
  • Project management skills, including ability to prioritize work in order to meet required deadlines
  • Problem solving ability
  • Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution

Basic Qualifications:

  • Graduate degree and 2 years of relevant work experience in the pharmaceutical industry

OR

  • Bachelors degree, and 4 years relevant work experience in the pharmaceutical industry
  • Minimum of 2 years experience in preparation of regulatory documents for public disclosure
  • Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information

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