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Clinical Document Management - Business Migrations Manager

5+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Document Management - Business Migrations Manager
Job ID: REQ-10039157
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular
Company / Legal Entity: Novartis Healthcare Private Limited


Role Overview

The Clinical Document Management (CDM) Business Migrations Manager is responsible for planning and executing migrations to and from Novartis' enterprise-wide clinical electronic document management systems (eDMS). This role ensures migration activities align with Novartis business needs, compliance, and operational requirements. The manager will partner with technical vendors, internal IT, and business stakeholders, contributing to the implementation of CDGM initiatives and process improvements.


Key Responsibilities

  • Migration Planning & Execution:
    Lead and manage the migration of clinical documents within Novartis' enterprise eDMS systems. Act as the main point of contact for migrations, ensuring alignment with business, compliance, and operational needs.

  • Collaboration:
    Work closely with internal stakeholders, including IT and business teams, especially during in-licensing and out-licensing activities, to determine migration requirements. Develop and maintain a migration roadmap based on system capabilities and future business priorities.

  • Process Improvement:
    Contribute to the development of efficient processes and integration of systems with eDMS, ensuring adherence to compliance and business priorities.

  • Training & Documentation:
    Serve as a subject matter expert (SME) on training materials and tools related to eDMS migration. Collaborate with the CDM Process Team and other key stakeholders to provide training and track migration progress.

  • Agile Methodology:
    Apply agile methodologies during development cycles to ensure smooth migration preparation and post-migration operations. Contribute to Incident Management, Change Management, and ongoing eDMS operations.

  • Vendor Oversight:
    Execute and monitor the vendor oversight plan, track service metrics, and identify opportunities to improve migration operations. Serve as the escalation point for any issues.

  • Inspection & Audits Support:
    Assist with inspections and audits by providing support for root cause analysis and the creation of corrective actions (CAPAs).


What You’ll Bring to the Role

  • Education & Experience:
    Advanced degree or a combination of a Bachelor’s degree in information or life sciences/healthcare and relevant industry experience. 6+ years of experience in Pharmaceuticals, Lifesciences, and Clinical Research, with 5+ years specifically in clinical document management and migration experience.

  • Experience with eDMS Systems:
    Hands-on experience with Veeva Clinical Vault, RIM, Documentum D2LS, or similar eDMS systems. Proven experience with Veeva migrations and leading migration activities for clinical and regulatory documents.

  • Agile Methodology:
    Strong knowledge of Agile practices in cross-functional teams, especially for releases and project management.

  • Communication & Leadership Skills:
    Strong influencing and presentation skills with the ability to effectively communicate at all levels. Proven ability to work collaboratively and manage migration projects in complex environments.


Why Novartis?

Novartis is committed to improving patient outcomes through innovative science and collaboration. In this role, you'll have the opportunity to contribute to the transformation of clinical document management processes and systems within a global organization.

For more details on Benefits & Rewards and People & Culture, visit their career site.


Join the Novartis Network:
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