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Senior Clinical Systems Analyst

Senior Clinical Systems Analyst

Stellent IT LLCCambridge, MA, United States
2 days ago
Job type
  • Temporary
  • Quick Apply
Job description

Job Title : - Senior Clinical Systems Analyst

Job Location : - Remote

Long Term Contract

Responsibilities

  • Gather user-customer requirements and translate the requirements into detailed technical specifications to be used in the solution design and implementation process.
  • Create the documentation required by the Clinical System group for project implementation, including user access and training plan, communications plan, and end user guides or training tools.
  • Support the creation and finalization of the documentation needed per validation / IS / project management teammates such as configuration workbook, system
  • impact assessment, test plan, test scripts, training plan, RAID logs, status reports, data migration plan, etc.
  • Review and execute test scripts and facilitate the UAT process
  • Works closely with end users and provides training to enhance user adoption across various clinical development functions that are involved with data review
  • Collaborates with other functional areas / departments and key stakeholders to maximize the use of the clinical data warehouse
  • Interface with the delivery team to
  • go beyond
  • simple requirements elicitation and help define solutions that leverage knowledge of industry trends in the clinical data management space

Required Knowledge, Skills, and Abilities

  • IT-literate and passionate / experienced with new technology and digital systems including Microsoft-based applications and Veeva Clinical Vault applications. eCS elluminate experience strongly desired but not required.
  • An experienced professional who is well versed in clinical study management activities, combined with excellent project management, training & mentoring capabilities
  • Previous experience supporting technologies in the clinical study management area, with an emphasis on GxP and compliance
  • Has a sound working knowledge of clinical data processes : EDC set-up; data flow / management of external clinical data coming from outside vendors; creation of SDTM and / or patient profiles; clinical data review process
  • Working knowledge of project management methodologies to work successfully with the assigned Project Manager
  • Excellent interpersonal and communication skills, both written and verbal
  • Must communicate clearly and effectively with both technical and non-technical stakeholders.
  • Excellent time management and organizational skills
  • Quality driven with a focus on attention to detail
  • Ability to work independently and take initiative
  • Flexible approach with respect to work assignments and new learning
  • Ability to prioritize workload and manage multiple and varied tasks with enthusiasm
  • Ability to work effectively in a matrix environment and to demonstrate, and foster, teamwork within the group, as well as across the organization
  • Required / Preferred Education and Experience

  • A minimum of a BA / BS, preferably in the scientific / healthcare and / or technology field
  • A minimum of 5 years of experience (Senior Manager) or 8yrs+ (Associate Director) in clinical related technology for the pharmaceutical / biotechnology industry
  • Knowledge of FDA / ICH guidelines and industry standard practices regarding the management of clinical trial data and studies.
  • Working knowledge of FDA Guidance Documents : Computerized Systems Used in Clinical Trials, General Principles of Software Validation.
  • Working knowledge of 21 C.F.R. Part 11
  • Consulting background with recent client facing experience.
  • Strong background in implementing and supporting GxP systems and computer systems validation process and documentation.
  • Well versed in GAMP 5 and Computer Systems Assurance
  • Knowledgeable about Software Development Life Cycle (SDLC) models.

    Sandip Kumar

    Sr. Tech Recruiter

    Email :

    sandip@stellentit.com

    Address : 505 Knolle Court

    Saint Augustine, FL 32092

    Telephone :

  • 1 321-641-0093
  • www.stellentit.com

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