Contract Clinical Systems Specialist

About the role

Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of pioneering scientific innovations in muscle biology. We are advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. This position supports the lifecycle management of clinical systems for Development Operations, reporting to the Director of Clinical Systems.

Responsibilities

• Plan, design, configure, and deploy new clinical systems and enhancements to existing applications; coordinate and participate in analyzing system requirements, user acceptance testing, and system enhancements.
• Support and enhance the Clinical Data Repository (CDR) system.
• Work with end users and subject matter experts 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 CRO 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).
• Serve as an internal clinical systems subject matter expert for end users.

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 processes 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.
• Background in clinical data management preferred.
• Strong interpersonal, written, and verbal communication skills.
• Strong analytical and problem-solving skills with attention to detail.
• Good organizational skills and ability to manage multiple tasks.

Pay

In the U.S., the hiring pay range for fully qualified candidates is $75-$86/hr. The base pay actually offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.