Clinical Documentation Specialist

1 day ago


Hyderabad Secunderabad Telangana, India beBeeClinical Full time ₹ 15,00,000 - ₹ 28,00,000

Job Title: Clinical Documentation Manager

Job Description

We are seeking a skilled and experienced Clinical Documentation Manager to join our team. In this role, you will be responsible for managing clinical documentation for various projects, including in-licensing, out-licensing, acquisitions, and divestments.

Key Responsibilities:
  • Act as the point of contact for assigned portfolios of projects, collaborating with key stakeholders from development informatics, legal, quality assurance, and global project teams.
  • Lead and/or contribute to the development of TMF transition plans, ensuring successful transitions of TMF documentation outside or into Novartis.
  • Develop and maintain document processes & standards relating to business development & licensing projects and out-licensing activities, in compliance with internal and external requirements & regulations.
  • Identify and communicate risks/trends/patterns relating to TMF, BD&L projects, out-licensing activities, and work with key stakeholders to define and implement pragmatic remediations.
Required Skills and Qualifications

To succeed in this role, you will need:

  • Minimum 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management.
  • Demonstrated success in planning and executing cross-functional projects.
  • Strong influencing and presentation skills. Ability to communicate effectively at all levels.
  • High organisational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
  • Good negotiation, problem-solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.
Language Proficiency

English is the primary language used in this role. Proficiency in English is required.

Work Environment

This role is based in [Location]. Candidates must be willing to work on-site.



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