Manager Development Records Management Systems- FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is looking for a Manager, Development Records Management Systems. This is a remote position in the United States.

The Manager, DRM Systems, Business Administrator (BA), for Vault Clinical is responsible for ensuring day to day business functioning of Vault Clinical modules. The BA will support DRM Systems, Business Process Owners (BPOs), and System Owner (SO) with the design, configuration, maintenance, validation and support of Vault Clinical which involves significant drive, engagement, and collaboration. The Manager will initiate discussions with vendors and establish demos or proof of concepts (POCs) as needed.

The BA drives the technical migration and QC of records and data into Vault Clinical with the migration vendor as well as integrations with other applications and systems. The BA is responsible to work with stakeholders to ensure requirements are documented, demos and POCs are accepted, testing is completed, and the system upgrade is implemented.

Job Duties:

• Manage day-to-day business functions of Vault Clinical modules, including maintaining and understanding the Vault Clinical data model.
• Serves as a point of contact for stakeholders (i.e., DRM, CTM, SSU, Monitoring, GD IT) across Global Development, as it relates to the Vault Clinical, its configuration, and the overall system landscape.
• Responsible for managing the implementation of new Veeva Vault Clinical features and their deployment, in collaboration with the Global Development IT (GD IT) team.
• Identify opportunities for process improvements and system enhancements, such as performing system health checks to identify and resolve and performance or process bottlenecks and issues and gathering user feedback.
• Develop and implement best practices for system use, liaising with Veeva and using industry knowledge.
• Drives migration of records and data into Vault Clinical and integrations with other applications and systems with appropriate reviewing and QC of output and deliverables.
• As automation and artificial intelligence opportunities become evident, the BA works with the AI vendor to ensure requirements are documented and clear, properly tested, and implemented correctly.
• Provides subject matter expertise on Vault Clinical to project teams and during vendor assessments.
• Collaborate with and drive interactions with vendors to implement new applications and functionality and to resolve system problems.
• Computer System Validation

• Responsible for the maintenance of the system’s validated state, involving significant drive and collaboration with technical unit, validation unit, business unit, and end users.
• Lead collection of enhancement and new functionality requests and drives collaboration and governance with BPOs to prioritize and implement said changes
• Advise internal and external stakeholders to ensure all business requirements are documented, accepted, and implemented
• Develops use cases, reviews proofs of concept (POCs) in lower environments, demos POCs to business, and verifies/validates user requirements to ensure the system functions correctly
• Authors and executes performance qualification (PQ) test scripts/protocols until system upgrade is deployed and implemented
• Supports review of validation documentation and risk impact assessments for business determination of impact and relevance to Sponsor
• Responsible for hypercare once the new version is implemented.
• Training
• Communicates new release information to the internal and external user community of 4000+ in an easy to understand and efficient manner.
• Support the drafting of system training material with the Change Management team for QRGs and presentations to ensure alignment with system functionality and configuration.
• Conduct train the trainer sessions for new system functionality, as needed
• Participate in F2F training, Office Hours and Knowledge Sessions, as needed
• Provide role training to new Business Admins
• End User Support:
• Provide internal and external end to end user support including triaging requests, troubleshooting, technical support, answering business process que