Manager Development Records Management Systems- FSP

myGwork - LGBTQ+ Business Community; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company is seeking a Manager for Development Records Management Systems. This remote role involves overseeing Vault Clinical modules, managing data migration, and ensuring system functionality. Ideal candidates will have extensive experience in GXP systems and excellent communication skills.

Qualifications

• 7+ years supporting GXP systems in the pharmaceutical/CRO industry.
• Experience with CTMS or related systems and data models.

Responsibilities

• Manage day-to-day business functions of Vault Clinical modules.
• Drive migration of records and data into Vault Clinical.
• Develop and implement best practices for system use.

Skills

Communication

Organizational

Multitasking

Education

Bachelor's Degree

Tools

Microsoft Office

Job description

2 days ago Be among the first 25 applicants

This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 the 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 for working with stakeholders to ensure requirements are documented, demos and POCs are accepted, testing is completed, and the system upgrade is implemented.

Job Duties

1. Manage day-to-day business functions of Vault Clinical modules, including understanding the Vault Clinical data model.
2. Serve as a point of contact for stakeholders (DRM, CTM, SSU, Monitoring, GD IT) across Global Development, related to Vault Clinical, its configuration, and the system landscape.
3. Manage the implementation of new Veeva Vault Clinical features and their deployment, in collaboration with the Global Development IT (GD IT) team.
4. Identify opportunities for process improvements and system enhancements, such as performing system health checks and gathering user feedback.
5. Develop and implement best practices for system use, liaising with Veeva and industry knowledge.
6. Drive migration of records and data into Vault Clinical and integrations, with appropriate review and QC.
7. Collaborate with AI vendors to ensure requirements are documented, tested, and implemented correctly for automation and AI opportunities.
8. Provide subject matter expertise on Vault Clinical during project teams and vendor assessments.
9. Coordinate with vendors for new applications, functionalities, and resolving system issues.
10. Maintain the system's validated state through collaboration with validation teams and end users.
11. Lead collection of enhancement requests and prioritize changes with BPOs.
12. Ensure all business requirements are documented, accepted, and implemented.
13. Develop use cases, review POCs, demos, and validate user requirements.
14. Author and execute performance qualification (PQ) test scripts until system upgrade deployment.
15. Support validation documentation review and risk assessments.
16. Manage hypercare after system upgrade.
17. Communicate new release information clearly to users.
18. Support drafting of training materials and conduct training sessions.
19. Provide end-user support, troubleshooting, and analysis of request trends.
20. Manage Business Content, document forms, templates, and data updates.
21. Oversee report, dashboard, and metric creation, maintenance, and improvement.
22. Develop documentation for reports and metrics, and present trends to leadership.
23. Support audits and regulatory inspections.
24. Coordinate with data stewards and privacy teams on data standards and privacy issues.
25. Supervise staff and contractors as necessary.

Job Requirements

• Understanding of database management and reporting.
• Knowledge of the TMF reference model is a plus.
• Excellent communication, organizational, and multitasking skills.
• Ability to work independently and in teams.
• Familiarity with clinical trial processes, ICH/GCP guidance, and essential documents.
• Experience with Computer System Validation and System Lifecycles.
• Knowledge of eTMF and CTMS systems, with Veeva Vault Clinical certification being a plus.
• Proficiency in Microsoft Office applications.

Minimal educational requirement: Bachelor's Degree.

Minimum experience: 7+ years supporting GXP systems in the pharmaceutical/CRO industry, especially with CTMS or related systems and data models.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Information Technology

Industries

• Pharmaceutical Manufacturing