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 capabilitiesPrevious experience supporting technologies in the clinical study management area, with an emphasis on GxP and complianceHas 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 processWorking knowledge of project management methodologies to work successfully with the assigned Project ManagerExcellent interpersonal and communication skills, both written and verbalMust communicate clearly and effectively with both technical and non-technical stakeholders.Excellent time management and organizational skillsQuality driven with a focus on attention to detailAbility to work independently and take initiativeFlexible approach with respect to work assignments and new learningAbility to prioritize workload and manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate, and foster, teamwork within the group, as well as across the organizationRequired / Preferred Education and Experience
A minimum of a BA / BS, preferably in the scientific / healthcare and / or technology fieldA minimum of 5 years of experience (Senior Manager) or 8yrs+ (Associate Director) in clinical related technology for the pharmaceutical / biotechnology industryKnowledge 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 11Consulting 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 AssuranceKnowledgeable 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 :
1 321-641-0093www.stellentit.com