Contract Clinical Systems Specialist

Cytokinetics

2d • $75 - $86 • Remote

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. The Contract Clinical Systems Specialist is responsible for supporting the lifecycle management of clinical systems for Development Operations. This position will provide support for clinical systems, such as the Clinical Data Repository (CDR), EDC, eTMF, Clinical Trial Management System (CTMS), and other digital technologies used in clinical trials. The Contract Clinical Systems Specialist will have expertise and practical experience in clinical trial management and clinical systems. The position will report to the Director of Clinical Systems. This role supports clinical data integration and other clinical systems, ensuring the development and validation of solutions to deliver on existing programs.

Requirements

• Bachelor’s degree in information technology, computer science, computer engineering, statistics, or bioinformatics with 3+ years of relevant experience supporting clinical systems within the biotech/life sciences industry, including data cleansing, analytics, and reporting
• Experience with EDC (Medidata Rave) and/or clinical data repository (CDR) systems
• Experience with MicroStrategy (dashboard, visualization & report development) or other data review tools
• Experience using Iron Python and SQL to develop and maintain scripts that perform tasks.
• Familiarity with database concepts, data validation and data model process from internal and external sources.
• Experience with data integration and ETL (extract, transform, load).
• Understanding of clinical trial data and regulations (CDISC, Good Clinical Practice, 21 CFR Part 11).
• Experience in developing business specifications/requirements and user acceptance testing for computer systems.
• Must possess good interpersonal skills
• Excellent written and verbal skills required.
• Must display strong analytical and problem-solving skills.
• Attention to detail required.
• Good organization skills, ability to manage multiple tasks

Nice To Haves

• Background of clinical data management preferred

Responsibilities

• Work on planning, design, configuration and deployment of new clinical systems and enhancements to existing applications; coordinate and participate in analyzing system requirements, user acceptance testing and system enhancements, as necessary
• Support and enhance the Clinical Data Repository (CDR) system
• Work with end users and SMEs to define clinical data visualization business requirements and data elements
• Develop and support clinical data analytics including patient profile and study dashboard
• Work with clinical systems vendors and CROs partners to transfer, integrate, and transform clinical data and operational data to Cytokinetics systems
• Develop and maintain clinical data automation scripts
• Provide training on different clinical systems, as necessary
• Support administration activities of clinical systems (e.g., user management)
• Support end users as an internal clinical systems subject matter expert

What This Job Offers

• Career Level: Mid Level