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Contract - Clinical Systems Specialist
4 months ago
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.
This role will work on visually presenting clinical data to decision makers with information used to optimize the drug development process. The position will report to the Director of Clinical Systems. This role supports clinical data integration and Spotfire as well as other clinical systems ensuring the development and validation of the 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.
* 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.
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.
Qualifications
* BS degree in information technology, computer science, computer engineering, statistics, or bioinformatics with 5+ years of relevant experience working with in Clinical Systems within the Biotech/Life Sciences industry providing cleansing, analytics, and reporting of clinical data.
* Experience with Tibco Spotfire (dashboard, visualization & report development) or other data review tools.
* Experience of 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.
* Background of data management or clinical data repository for clinical trials preferred
* 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 organization skills, ability to manage multiple tasks.
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Salary Pay Range
$100-$120 USD
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.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer