Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
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 Senior 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 eTMF, Clinical Trial Management System (CTMS), EDC, and other digital technologies used in clinical trials. The Senior Clinical Systems Specialist has 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.

QUALIFICATIONS

• BS degree in information technology, computer science, computer engineering, statistics, or bioinformatics with 5+ years of relevant experience working with Clinical Systems within the Biotech/Life Sciences industry
• Direct clinical systems experience (CTMS, EDC, eTMF, digital technologies for clinical trials, etc.)
• Experience working with Veeva clinical applications
• PC literacy required; common MS application skills SharePoint, Outlook, Word, Excel, PowerPoint, Visio)
• Understanding of clinical trial operations and regulations (Good Clinical Practice, 21 CFR Part 11)
• Experience in developing business specifications/requirements and user acceptance testing for computer systems
• 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).
• Knowledge of AI technology preferred
• Must possess good interpersonal skills.
• Excellent written and verbal skills required. Must display strong analytical and problem-solving skills. Attention to detail required.
• Good organizational skills, ability to manage multiple tasks.

PAY RANGE:

In the U.S., the hiring pay range for fully qualified candidates is $120,000 - $170,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

• 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 the Development Operations team in managing the systems vendor relationship on a day-to-day basis to ensure optimum system performance and to address/escalate issues, as appropriate.
• Develop Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems.
• Provide training on different clinical systems, as necessary.
• Support administration activities of clinical systems (e.g., User Management).
• Partner with IT, Quality Systems, and other stakeholders on all clinical system bug fixes and upgrades. Support end users as an internal clinical systems subject matter expert.
• Oversee governance for clinical systems, as applicable.
• Work with clinical systems vendors and CRO partners to transfer, integrate, and transform clinical data and operational data to Cytokinetics systems.