System Administrator - Veeva Vault - Jobs in Toronto, ON

Job Description

Position Title: System Administrator, TMF/Clinical OperationsPosition Location: CanadaPosition Reports To: Sr. Manager, TMF OperationsDepartment/Unit Name: TMF OperationsWe are looking for a technically minded individual with System Administrator and GxP experience to join our talented and collaborative TMF Operations team, within Alimentiv Clinical Operations.JOB SUMMARY:The System Administrator is primarily responsible for the management and maintenance of the Veeva Vault eTMF platform as part of the execution and oversight of clinical trials in accordance with regulations and SOPs. Working closely with TMF Operations and TMF stakeholders to maximize system functionality; improve system efficiency, effectiveness and expand system capabilities ensuring business needs are maintained.Oversee the business-critical system requirements for Veeva Vault eTMF to ensure the system adheres to Alimentiv system-related procedures.Technical Lead for migration of legacy studies into Veeva Vault eTMF platform. Responsible for extraction, mapping, and creation of the Data Loader Sheets for TMF Objects and related object records for upload into the Vault eTMF Application and post-upload verification to ensure transfer accuracy with completion of the Migration Summary Report.Acts as the Technical System Expert (TSE) for other systems utilized by TMF Operations (Medidata CTMS and BOX) for delivery of the TMF and assists with system administration tasks within Clinical Operations.KEY AREAS OF RESPONSIBILITY:

• Configuration, validation and maintenance of Veeva Vault eTMF platform as per business needs in alignment with Alimentiv’s business requirements, corporate procedures, and regulatory requirements
• Responsible for Change Management: Coordinate with the vendor for product releases, lead internal review of changes and utilize change control process to implement change requests
• Oversee the development of system requirements, any design or process changes related to the system
• Primary contact (Vendor Lead) with vendor for resolving any major incidents/defects within Veeva Vault eTMF platform
• Responsible for ensuring that the system contains the correct framework to support data governance and quality
• Develops and implements the data governance plan
• Assists in the conduct of the risk assessment
• Oversight on instructional materials for role-based utilization by stakeholders and facilitate end user support to ensure successful adoption and understanding of the applications
• Participate in the strategy, management and integration of systems that impact the TMF, including assessment of vendors and technology
• Provide additional support, access, and management of system users
• Collaborate with multiple teams across different geographies and time zones
• Work on special assignments or perform other related duties on an as needed basis.

QUALIFICATIONS:Education and Experience Required

• Three to five years of experience in administering Computerized Systems in a pharmaceutical or Life Science industry
• Degree in Computer Science, Engineering, Technology or equivalent
• Experience with system configuration and Computer System Validation (CSV)

Assets

• Certification(s) in Veeva Administration, Veeva Vault desired
• Experience with GxP system and application monitoring and data analytics
• Experience working and collaborating in cross-functional global team environment.
• Project Management experience

WORKING CONDITIONS:

• Home-based

• Accommodations for job applicants with disabilities are available upon request

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