Cytokinetics

Empowering Muscle Empowering Lives

Contract Clinical Systems Manager

ManagerManagerContractRemoteTeam 201-500Since 1998H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

$110 - $120 / hour

Bachelor Degree7 yrs expEnglish

Job Description

• 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

Job 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.

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