Manager Development Records Management Systems- FSP
United States of America, RemoteJob ID R0000033600 Category Clinical Trials
About this Role
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 questions related to system, and performing analysis on request trends
- Liaise with Veeva, GD IT, and Corporate IT as appropriate to discuss “bugs” and functionality “best practices” for proper implementation
- Manage Business Content within the system
- Work with BPOs to manage and version document forms and templates
- Manage business process driven values, metadata, and controlled vocabularies and picklists
- Manage data updates and deletion of certain critical / protected data
- Dashboards, Reports, Metrics
- Leads and oversees the creation, maintenance, retirement, and improvement of reports, dashboards, and saved views based on user needs.
- Develop & implement documentation to ensure that users understand the definitions of the dashboard, report, or metric
- Provide sensitive and/or compliance information to Sr. Leadership as requested.
- Recommend new tools that will improve processes within Global Development.
- Prepare and present trends, metrics and issue reports and presentation to Sr. Leadership as required.
- Supports internal audits and regulatory inspections as required.
- Coordinate with the data stewards and with the Privacy Coordinators on issues regarding data standards and data privacy. Ensure proper documentation is generated.
- Supervise staff/contractors as necessary.
Job Requirements:
- Understanding and working knowledge in database management
- Demonstrated understanding of database reporting
- Understanding of theTMF reference model a plus
- Proficient in oral and written communication, excellent organizational skills and the ability to manage multiple tasks with great attention to detail
- Good interpersonal skills with an ability to work in a team environment and independently
- Must be flexible and able to handle a face paced environment
- Familiarity with clinical trial processes and ICH/GCP guidance and working knowledge of essential documents
- Ability to think critically and problem solve
- Knowledge of and experience with Computer System Validation and System Lifecycles
- Knowledge of eTMF and CTMS systems (Veeva Vault Clinical a plus)
- Veeva Vault Certified Administrator a plus
- Proficient in Microsoft Office software applications
Minimal Educational requirements: Bachelor's Degree
Minimum Years of Experience: Bachelor's Degree with 7+ years of relevant experience supporting GXP systems in Pharmaceutical/CRO industry, the majority of which was involved with the technical aspects of the CTMS or related system and understanding the data model / structure.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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