Senior Clinical Systems Specialist

Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass 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.

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 the Development Operations team in managing the systems vendor relationship on a daytoday 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.

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 problemsolving skills. Attention to detail required.

• Good organizational skills ability to manage multiple tasks.

Pay Range:

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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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.

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Cytokinetics is an Equal Opportunity Employer