Document Migration Strategist

1 day ago


Dublin, Dublin City, Ireland beBeeClinical Full time €90,000 - €120,000

The Clinical Document Governance Management (CDGM) department is responsible for the strategic direction and implementation of clinical document management systems, processes, and standards. They also oversee the operations of CDM services, including Trial Master File (TMF) management, clinical submission readiness, record retention, TMF integrations for business development and licensing deals, archiving, and enhancing Good Documentation Practice capability worldwide.

About The Role

We are seeking a knowledgeable and experienced Business Migrations Manager to handle the strategy, planning, and delivery of technical migrations to, from, and within our enterprise-wide clinical electronic document management systems. This role will be pivotal in implementing CDGM initiatives, projects, and process improvement activities.

Responsibilities
  • Lead the implementation of CDGM initiatives to enhance the planning and execution of technical migrations.
  • Liaise with internal and external stakeholders to plan and execute technical migrations, ensuring alignment with business, compliance, and operational requirements.
  • Collaborate with stakeholders to identify and agree on migration business requirements, understand source and target system capabilities, and develop a future technical migration roadmap.
  • Serve as a Subject Matter Expert for training materials and tracking tools for eDMS technical migration activities.
  • Manage activities related to migration-related Incident Management, Change Management, and ongoing operations of the eDMS.
  • Support the forecasting of internal resource allocations and vendor-provided activities as part of eDMS migration roadmap management.
  • Execute the vendor oversight plan, monitor service metrics, and identify opportunities for improvement.
  • Provide support for inspections/audits, contribute to root cause analysis, and creation/delivery of CAPAs.
Requirements
  • A strong background in information or life sciences/healthcare, combined with relevant industry experience.
  • A minimum of 6 years of experience in Pharmaceuticals, Life sciences, and Clinical Research, with specific experience in leading clinical document management, TMF, and/or records & information management technical migration.
  • A minimum of 5 years of full-scale technical migrations of clinical documents, particularly eTMF.
  • At least 2 major experiences in Veeva Vault related technical migrations.
  • Prior experience and knowledge of Trial Master File (TMF) reference model.
  • Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory (e.g. Veeva Clinical Vault, RIM, Documentum D2LS).
  • Deep knowledge of Agile working methodologies.
  • Strong influencing and presentation skills, with the ability to communicate effectively at all levels.
Desired Skills

Clinical document management technical migration, data analysis, risk monitoring, trends analysis, Veeva Vault, TMF.

Why Us: We help people with disease and their families by developing innovative treatments and solutions. Our team is passionate about delivering exceptional results and making a positive impact.

Commitment To Diversity & Inclusion: We strive to build an inclusive work environment that reflects the diversity of our patients and communities.

Benefits and Rewards: We offer a comprehensive benefits package and competitive compensation to support your personal and professional growth.



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