Senior Clinical Document Management Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeClinical Full time

Job Description

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  • Drive the planning and execution of migrations to and from electronic document management systems (eDMS) in line 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 migration roadmap.">
  • Contribute to activities ensuring efficient processes and integrations of systems with eDMS based on a strong understanding of enterprise systems landscape and compliance priorities.">
  • Plan and contribute to agile working methodologies during development cycles to prepare for migration and during post-migration hypercare periods.">
  • Own or contribute to activities related to migration incident management, change management, and ongoing operations of the eDMS.">
  • Support forecasting of internal resource allocations and vendor-provided activities as part of eDMS migration roadmap management.">
  • Execute vendor oversight plans, monitor service metrics, and identify opportunities for improvement to the operating model in relation to migration. Act as a point of escalation for issues.">
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Required Skills and Qualifications

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  • Advanced degree or combination of Bachelor's degree in information or life sciences/healthcare and relevant industry experience. Minimum of 6 years working in pharmaceuticals, life sciences, and clinical research with specific experience in contributing and leading clinical document management, TMF, and/or records & information management.">
  • Minimum of 5 years of full-scale migrations.">
  • Minimum 2 medium to major Veeva-related hands-on and provable experience in leading and planning of migrations.">
  • Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory, highly desired.">
  • Business-relevant technical and working experience of eDMS systems like Veeva Clinical Vault, RIM, Documentum D2LS, or similar.">
  • Knowledge of industry-wide Electronic and Clinical Document Management systems and features.">
  • Deep knowledge of Agile way of working with cross-functional teams for releases.">
  • Strong influencing and presentation skills. Ability to communicate effectively at all levels.">
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Skills Desired

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Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis

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