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Clinical Document Management - Business Migrations Manager

5+ years
Not Disclosed
10 Feb. 19, 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
Company: Novartis Healthcare Private Limited


About the Role:

The Clinical Document Management (CDM) Business Migrations Manager is responsible for overseeing the planning and execution of migrations to and from Novartis’ clinical electronic document management systems (eDMS). This role involves working closely with business and technical stakeholders to ensure that migrations align with business needs, compliance, and operational requirements.

You will be responsible for driving the transformation of the Trial Master File (TMF) system and ensuring efficient integration of systems with eDMS. You will lead migration projects, contribute to process improvement activities, and manage vendor relationships.


Key Responsibilities:

  • Migration Planning and Execution:

    • Plan and manage migrations to and from Novartis eDMS.

    • Work closely with CDGM, IT, and business stakeholders to align business needs with migration activities.

    • Contribute to identifying and developing future migration roadmaps, especially for in-licensing and out-licensing activities.

  • Process Improvement:

    • Contribute to enhancing processes and integrations of systems with eDMS.

    • Serve as the Subject Matter Expert (SME) for migration-related training materials, tracking tools, and processes.

  • Agile Methodologies:

    • Support the application of agile working methodologies during development cycles and post-migration hyper-care periods.

  • Incident and Change Management:

    • Oversee migration-related incidents and manage change processes effectively.

    • Support forecasting of internal resource allocations and vendor activity.

  • Vendor Management:

    • Monitor service metrics for migration-related vendors and identify opportunities for operational improvements.

    • Act as a point of escalation for migration-related issues.

  • Compliance and Support:

    • Support inspections/audits and contribute to root cause analysis and corrective/preventive actions (CAPAs).


Minimum Requirements:

  • Education:

    • Advanced degree or combination of a Bachelor's degree in information sciences, life sciences, healthcare, or a related field.

  • Experience:

    • At least 6 years of experience in Pharmaceuticals, Lifesciences, and Clinical Research.

    • Minimum 5 years of experience in full-scale migrations and 2 successful Veeva-related migrations.

    • Expertise in Electronic Document Management systems (e.g., Veeva Clinical Vault, Documentum D2LS).

  • Skills:

    • Strong knowledge of industry-standard eDMS systems and Agile methodologies.

    • Excellent influencing and presentation skills, capable of communicating across all organizational levels.


Why Novartis?

At Novartis, we are committed to improving patients' lives by fostering a community of passionate people who collaborate to make breakthroughs. We offer a supportive and inclusive work environment where you can grow professionally and contribute to innovations in healthcare.

  • Diversity & Inclusion: Novartis promotes a diverse and inclusive culture.

  • Benefits & Rewards: Learn more about benefits and rewards.


How to Apply:

To apply for this role, visit the Novartis Career Portal and submit your application.


Additional Information

  • Accessibility: If you need reasonable accommodation due to a medical condition or disability, please reach out to diversityandincl.india@novartis.com for assistance.


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