AssociateClinical Trial Registry Writer, Chorus

AssociateClinical Trial Registry Writer, Chorus #aws #cloud #cloudcomputing #azure #devops #technology #python #amazonwebservices #linux #amazon #programming #awscloud #cybersecurity #coding #googlecloud #developer #kubernetes #bigdata #datascience #microsoft #machinelearning #software #java #tech #it #gcp #awstraining #javascript #security #docker At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring lifechanging medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We re looking for people who are determined to make life better for people around the world. PURPOSE OF THE JOB: The Associate, Clinical Trial Registry Writer will be supporting Chorus, a Division of Lilly Research Laboratories, which is a virtual development organization that manages a broad portfolio of New Molecular Entities from Candidate Selection through Clinical Proof of Concept. Chorus collaborates with a network of external experts to devise clinical strategy, design protocols, conduct experiments and provide data to inform development. Chorus seeks to conduct studies that have highest impact on probability of technical success in an efficient manner, while managing uncertainty and optimizing investment in secondary goals. The Chorus model seeks to advance molecules through the drug development cycle or enable clear termination decisions based on efficient proofofconcept studies. The purpose of the Chorus Clinical Trial Registry CTR Writer 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 for all assets in the Chorus portfolio. The Chorus CTR Writer will spend the majority of their time supporting the design, delivery, accuracy and maintenance of clinical information resources and databases ensuring compliance with global Clinical Trial Registry and other Global regulatory reporting databases in a timely manner. CORE JOB TASKS : Clinical Trial Registry and Results Planning, Development, Finalization and Document Management: Rolebased Training Plan Clinical Operations II Contribute to the development, maintenance, and implementation of policies andor procedures on clinical trial registry and clinical trial results database processes and associated workflows. Identify studies required for registry and results postings. Ensure that responsible functions are aware of associated timelines and deadlines. Maintain external focus by keeping abreast of emerging global industry posting and transparency requirements and provide guidance and training to CRCs and Chorus colleagues to ensure compliance and inspection readiness for molecules within Chorus portfolio. 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 result entries. Manage access rights to applicable systems as needed. Serve as the Chorus Subject Matter Expert regarding regulations and guidelines for posting within CT registries. In addition, provide interpretation, direct input into Quality systems, and influence Chorus direction to comply with external and internal expectation of posting study information. Develop and provide education and training as required to internalexternal groups. Define and monitor applicable metrics to support overall compliance. Maintain and enhance knowledge of global CTR regulations and guidelines. Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc. Complete and maintain the EU CTA application form within EudraCT as well as any subsequent information being entered into EudraCT during the products lifecycle. Maintain all information being entered CT.gov during the product s lifecycle. Collaborate with teams internal and external to Chorus across multiple geographies and phases of drug development. Lead crossfunctional clinical teams to create and maintain current clinical trial study information for Chorus and External Partner portfolio assets in compliance to global transparency standards for Registration and Results Reporting requirements. Inform and interpret changes in transparency requirements globally for Chorus. Communicate to management, teams, peers, and business partners to ensure compliance to reporting requirements. Knowledgeexperience with writing Lay Summaries i.e., Plain Language summary and redacting information from regulatory documentation. Project Management Influence Knowledge Sharing: Rolebased Training Plan Clinical Operations II 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 reoccurrence 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. MINIMUM JOB REQUIREMENTS e.g., educational background, work history, etc.: 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 highlevel enduser computer skills MS office applications: Word, Excel, PowerPoint, etc.. Demonstrated mastery of English language skills written and spoken. MISCELLANEOUS: Experience with CTR processes and databases. Experience in biostatistics, medicalregulatory writing. Experience with term and literature searches both internal and external to Lilly. 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 crossfunctionally at all levels. Ability to influencelead others. Ability to work well across cultures and time zones. Willingness to travel as required.