Senior Document Management Lead
2 weeks ago
We are seeking a highly skilled Senior Manager to lead our document and process management efforts.
Key Responsibilities- Develop business requirements for CTMS management, ensuring quality, completeness, and timeliness of study, country, and site operational data.
- Identify interdependencies with other relevant CTMS modules/capabilities to streamline clinical trial operations.
- Create and manage control documents and supporting materials to ensure repeatable, predictable, and scalable business processes.
- Collaborate with cross-functional teams to gather feedback and understand needs to identify valuable improvements.
- Drive continuous improvement by shaping CTMS strategies to align with evolving industry standards and regulations.
- Monitor CTMS metrics and address performance, data quality, and usability issues in a timely manner.
- Provide and continuously improve CTMS training, support user community, and maintain resources like FAQs and communication plans.
The successful candidate will advocate for the introduction and integration of innovative technologies that bolster our document management and communication operations.
Leadership & Team CollaborationThe Senior Manager will lead and support CTMS-related meetings, including Superuser and Operational Working Group, and present to stakeholders as needed.
Requirements- Relevant experience with Clinical Trials, documents, and responsibilities internal and external to the organization.
- Subject Matter Expertise in CTMS, TMF, and Organization/Person Profile Management.
- Ability to communicate complex issues to internal and external partners driving effective decision-making.
- Proven experience in a multi-disciplinary environment.
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