job title: Associate - clinical trial registry writing(eli lilly)

Roles and Responsibilities

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.

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.
▪ Willingness to travel as required.