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Associate -Clinical Trial Registry Writing

Associate -Clinical Trial Registry Writing

ConfidentialBengaluru / Bangalore
30+ days ago
Job description

Organization Overview :

The purpose of the Associate, GSC Clinical Trial Registry Writing is to support the development and implementation of Clinical Trial Registry (CTR) systems and processes, ensuring Global transparency regulations and requirements are described and

implemented and that there are monitoring systems (and metrics) in place to ensure compliance. The CTR writer will

collaborate with cross-functional, multidisciplinary teams across multiple geographies and phases of drug development to

ensure / coordinate the accurate and timely posting of applicable clinical trial protocol information and study results.

Responsibilities :

  • Clinical Trial Registry and Results Planning, Development, Finalization and Document Management
  • Contribute to the development, maintenance, and implementation of policies and / or procedures on clinical trial registry and clinical trial results database processes and work flows. Identify opportunities for process improvements.
  • Identify studies required for registry and results postings. Ensure that responsible functions are aware of timelines and
  • deadlines.
  • Collaborate cross functionally with applicable team members and departments (e.g.,biostats, medical, clinical trial
  • management), to obtain data required for completion of registry and results entries.
  • Manage access rights to applicable systems as needed.
  • Serves as subject matter expert on CTR database requirements.
  • Develop and provide education and training as required to internal groups.
  • Define and monitor applicable metrics to support overall compliance.
  • Maintains and enhances knowledge of CTR regulations and guidelines.
  • Exhibits flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.
  • Project Management / Influence / Knowledge Sharing
  • Supports the systems and process for CTR and works with other team members to ensure consistent practices are
  • monitored and employed globally.
  • Provides input to deliver innovative solutions, preventing re-occurrence of issues.
  • Escalates issues in a timely and appropriate manner.
  • Ensures the evaluation (monitoring) of the CTR processes and communicating changes to the processes to the business. Shares key learning to drive simplification and replicate best practices.

Basic Requirements :

  • Bachelor s degree in scientific, health, communications, or technology related field
  • Or, Bachelor s degree in any field with at least two years of clinical development experience.
  • Demonstrated high-level end-user computer skills (MS office applications : Word, Excel, PowerPoint, etc.).
  • Demonstrated mastery of English language skills written and spoken.

    • Additional Skills / Preferences :

  • Experience with CTR processes and databases.
  • Experience in biostatistics, medical / regulatory writing.
  • Verbal reasoning, attention to detail, critical thinking, and analytical ability.
  • Demonstrated project management and time management skills.
  • Ability to be flexible in varying environments and with multiple customer groups.
  • Able to work independently as well as part of a team : able to take initiative and responsibility, following through and
  • completing assigned tasks.
  • Able to deal with ambiguity and to plan, prioritize, and manage conflicting priorities.
  • Experience working within multiple functional areas across medical, regulatory and legal.
  • Strong interpersonal and negotiation skills - Ability to manage upwards.
  • Strong medical research background with demonstrated breadth and depth of knowledge of medical research processes
  • throughout all phases of development.
  • Developed networks and proven ability to influence cross-functionally at all levels.
  • Ability to influence / lead others.
  • Ability to work well across cultures and time zones.

    • Role :   Healthcare & Life Sciences - Other

    Industry Type :   Pharmaceutical & Life Sciences

    Department :   Healthcare & Life Sciences

    Employment Type :   Full Time, Permanent

    Role Category :   Healthcare & Life Sciences - Other

    Education

    UG :   Any Graduate

    PG :   Any Postgraduate

    Skills Required

    Time Management, biostatistics , Analytical, clinical development

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