Senior Clinical Systems Analyst

Senior Clinical Systems Analyst within Clinical Business Operations – Clinical Systems. A division of Clinical Operations.

This role is scoped as a Senior Manager to Associate Director level. Leveling will be based on your overall experience.

About Us
This is a precision therapy company focused on genomically defined cancers, rare diseases, and cancer immunotherapy. We are committed to transforming the lives of patients with complex diseases through our innovative medicines. Our team embodies our core values of Patients First, Trust, Optimism, Thoughtfulness, and Urgency in everything we do.

Summary
We are striving to improve all aspects of clinical trial management. As part of this, we are adopting a clinical data warehouse technology to enable efficient review and analysis of data and data cleaning. The Clinical Systems Analyst sits on the clinical data warehouse implementation team and is the primary liaison to the end users. You will support collection of user specification requirements, help build the system specifications, take part in user acceptance testing and follow up with end users to ensure we are realizing the full potential of the technology. The Clinical Systems Analyst will demonstrate a good understanding of the functionality of the clinical data warehouse and support end user training and adoption. Other clinical systems may become part of the scope of this role, but we expect this role to focus on the clinical data warehouse for the foreseeable future.

esponsibilities

• 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.