Contract Clinical Systems Manager
Cytokinetics
contract
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $110 - $120 per hour
About the role
- Lead GxP system evaluations and assess vendor validation packages
- Oversee clinical study vendor GxP systems changes and lifecycle deliverables
- Ensure clinical study systems comply with applicable regulations and guidance (e.g., 21 CFR Part 11, Annex 11, ICH E6(R2/R3))
- Support internal/external audits and regulatory inspections (including audit trail review strategy)
- Maintain inspection-ready documentation
- Establish governance for change control, periodic review, and system lifecycle management
- 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 systems vendor relationships 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
- Partner with IT, Quality Systems, and other stakeholders on clinical system bug fixes and upgrades
- 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
Requirements
- BS degree in information technology, computer science, computer engineering, statistics, or bioinformatics
- 7+ years of experience supporting GxP computerized systems in clinical research environments (sponsor, CRO, or biotech)
- Strong expertise in GxP validation principles (CSV lifecycle and risk-based validation)
- Hands-on experience with major clinical platforms (e.g., Veeva eTMF, Medidata Rave EDC & CTMS, IRT/RTSM, RBQM/RACT, CDR)
- Demonstrated experience leading system evaluations, validation deliverables, and UAT oversight
- Working knowledge of global regulatory expectations (FDA, EMA, MHRA)
- 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
- Familiarity with database concepts, data validation, and data model process from internal and external sources
- 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
Benefits
- Our employees come from different backgrounds, and we celebrate those differences.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxP validation principlesCSV lifecyclerisk-based validationuser acceptance testingclinical platformsdata validationdatabase conceptsbusiness specificationsclinical trial dataAI technology
Soft Skills
interpersonal skillswritten communicationverbal communicationanalytical skillsproblem-solving skillsattention to detailorganizational skills