Clinical Documentation Manager

3 days ago


Hyderabad Secunderabad Telangana, India beBeeBusinessDevelopment Full time

About this role

This position involves leading and collaborating with cross-functional teams to ensure seamless transitions of documentation related to business development and licensing projects.

The ideal candidate will have strong organizational awareness, excellent influencing and presentation skills, and the ability to communicate effectively at all levels.

Additionally, they will have experience working in multi-disciplinary teams, across cultures and geographies, and be able to establish trusted relationships with internal and external stakeholders.

  • Key Responsibilities:
  • Act as point of contact for assigned portfolio of business development and licensing projects.
  • Collaborate with key stakeholders to develop TMF transition plans and ensure successful transitions.
  • Maintain paper and electronic document processes & standards relating to business development and licensing projects.
  • Identify and communicate risks/trends/patterns and work with stakeholders to define and implement remediations.
  • Execute vendor oversight plan, monitor service metrics, and identify opportunities for improvement.
  • Serve as Subject Matter Expert on TMF transition related training materials and tracking tools.
  • Provide support for inspections/audits and contribute to root cause analysis identification.

Required Skills and Qualifications

  • 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: English

Keyword: Business Development Specialist



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