Contract Clinical Systems Specialist

📋 Description

• • Cytokinetics, a specialty biopharmaceutical company with over 25 years of pioneering scientific innovation in muscle biology, is seeking a highly motivated Contract Clinical Systems Specialist to join our Development Operations team. This role is crucial in supporting the lifecycle management of our clinical systems, ensuring the efficient and effective execution of clinical trials. You will play an integral part in advancing our mission to improve the lives of patients suffering from diseases of cardiac muscle dysfunction by providing expert support for critical digital technologies.
• • As a Contract Clinical Systems Specialist, you will be instrumental in the planning, design, configuration, and deployment of new clinical systems, as well as implementing enhancements to existing applications. This involves close collaboration with cross-functional teams to analyze system requirements, coordinate user acceptance testing (UAT), and drive system improvements. Your contributions will directly impact the quality and integrity of our clinical data and trial operations.
• • A key responsibility of this role is to provide dedicated support and enhancement for the Clinical Data Repository (CDR) system. You will work closely with end-users and Subject Matter Experts (SMEs) to meticulously define business requirements for clinical data visualization and identify essential data elements. This ensures that our data infrastructure is robust and capable of supporting advanced analytical needs.
• • You will be actively involved in developing and supporting clinical data analytics, including the creation of patient profiles and study dashboards. This involves translating complex data into actionable insights that inform decision-making throughout the clinical development process. Your work will help visualize trial progress and patient outcomes, contributing to a deeper understanding of our investigational therapies.
• • Collaboration with external partners, including clinical systems vendors and Contract Research Organizations (CROs), is a significant aspect of this position. You will manage the transfer, integration, and transformation of both clinical and operational data into Cytokinetics' internal systems, ensuring data accuracy, consistency, and compliance.
• • The role also entails developing and maintaining clinical data automation scripts to streamline processes and improve efficiency. This requires a strong understanding of scripting languages and data manipulation techniques to automate repetitive tasks and enhance data workflows.
• • Providing comprehensive training on various clinical systems to end-users and stakeholders will be part of your responsibilities. This ensures that all users are proficient in utilizing the systems effectively, maximizing their utility and adoption across the organization.
• • You will also support the day-to-day administration of clinical systems, including essential activities such as user management, access control, and system configuration. This ensures the smooth operation and security of our clinical technology landscape.
• • As an internal clinical systems subject matter expert, you will provide ongoing support to end-users, troubleshooting issues, answering queries, and offering guidance on best practices for system utilization. Your expertise will be invaluable in resolving challenges and optimizing the use of our clinical systems.
• • This position requires a proactive approach to identifying opportunities for system optimization and process improvement within the clinical development operations. You will contribute to the continuous enhancement of our technology infrastructure, ensuring it remains at the forefront of industry standards.
• • The ideal candidate will possess a strong understanding of clinical trial data, regulatory requirements (such as CDISC, Good Clinical Practice, and 21 CFR Part 11), and data management principles. This knowledge is critical for ensuring compliance and maintaining the highest standards of data integrity throughout the clinical trial lifecycle.
• • You will be expected to develop detailed business specifications and requirements for new system functionalities and participate in rigorous user acceptance testing to validate system performance and usability before deployment.
• • While not strictly required, a background in clinical data management is preferred, as it will provide a strong foundation for understanding the nuances of clinical trial data and its handling.
• • The role demands excellent interpersonal skills, enabling effective communication and collaboration with diverse teams and external partners. Strong analytical and problem-solving skills, coupled with meticulous attention to detail, are essential for success in this position. The ability to manage multiple tasks effectively and maintain strong organizational skills is also paramount.