Clinical Document Migrations Manager

7 days ago

hyderabad, India Novartis Full time

Job Description SummaryThe Clinical Document Governance Management (CDGM) is responsible for the strategy and implementation of clinical document management (CDM) systems, processes, and standards; as well as the operations of CDM services, which include Trial Master File (TMF) management, clinical submission preparedness, record retention, TMF integrations for BD&L deal, archiving and enhancing Good Documentation Practice capability worldwide in Novartis. Additionally, CDGM spearheads the transformation of TMF at Novartis by pioneering the adoption of revolutionary technologies, processes, and working methods.We are seeking a knowledgeable and experienced Clinical Document Management - Business Migrations Manager to handle the strategy, planning and delivery of technical migrations to, from, and within Novartis enterprise-wide clinical electronic document management systems. This role will be pivotal in implementing the Clinical Document Governance Management initiatives, projects, and process improvement activities. Job DescriptionResponsibilities: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 Novartis 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:Advanced degree or a 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 leading of clinical document management, TMF and/or records & information management technical migration.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. Ability to communicate effectively at all levels.Desired Skills:Clinical document management technical migration, Budget Management, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Life sciences, Risk Monitoring, Trends Analysis, Veeva Vault, TMF.Skills DesiredBudget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model

  • Clinical Documentation Specialist

    2 weeks ago

    Hyderabad, Telangana, India Mancer Consulting Services Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Major Responsibilities:Manage multiple CDI teams and leads; drive quality, efficiency, and complianceDefine and implement standardized workflows aligned with enterprise goalsPartner with US and India leadership on training, reporting, and process improvementsLead team hiring, onboarding, training plans, and capability enhancementConduct regular quality...

  • Clinical Documentation Specialist

    1 week ago

    Hyderabad, India Mancer Consulting Services Full time

    Job Description Major Responsibilities: - Manage multiple CDI teams and leads; drive quality, efficiency, and compliance - Define and implement standardized workflows aligned with enterprise goals - Partner with US and India leadership on training, reporting, and process improvements - Lead team hiring, onboarding, training plans, and capability enhancement...

  • Clinical Documentation Integrity Lead

    4 days ago

    Hyderabad, India Mancer Consulting Services Full time

    - Bachelor’s degree in Health Sciences, or equivalent; Master’s - 12+ years of CDI or related clinical coding experience, with 4+ years in management - CDI certification (CCDS, CDIP) or AHIMA/AAPC credential is a strong plus - Strong stakeholder engagement, coaching, and changing management skills12+ years of experience in Clinical Documentation...

  • Clinical Documentation Specialist

    2 weeks ago

    Hyderabad, Telangana, India VMD Tech Assist Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Role & responsibilities :Review and summarize patient medical records and clinical notes.Ensure accuracy and completeness of clinical documentation.Collaborate with billing and coding teams for data clarification.Maintain confidentiality and adhere to HIPAA compliance.Meet daily quality and productivity targets.Learn and work efficiently on EHR/EMR...

  • Clinical Research Documentation Specialist

    6 days ago

    Ameerpet, Hyderabad, Telangana, India Forward Life Pvt. Ltd Full time ₹ 2,64,000 per year

    Role Overview:The Clinical Research Documentation Specialist supporting the Head of the Ethics Committee (EC) Division plays a key role in ensuring all documentation is accurate, compliant, and audit-ready. This position requires managing end-to-end responsibilities related to clinical research documentation in alignment with regulatory, institutional, and...

  • Clinical Data Manager

    2 weeks ago

    Hyderabad, India Clinovo Full time

    OVERVIEW:· The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing.· comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases.· The CDM is recognized as the platform expert,...

  • Clinical Data Manager

    2 weeks ago

    Hyderabad, India Clinovo Full time

    OVERVIEW: · The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing. · comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. · The CDM is recognized as the platform expert,...

  • Clinical Data Manager

    2 weeks ago

    Hyderabad, India Clinovo Full time

    OVERVIEW: · The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing. · comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. · The CDM is recognized as the platform expert,...

  • Clinical Data Manager

    2 weeks ago

    hyderabad, India Clinovo Full time

    OVERVIEW:· The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing.· comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases.· The CDM is recognized as the platform expert,...

  • Clinical Data Manager

    3 weeks ago

    Hyderabad, India Whatjobs IN C2 Full time

    SUMMARY Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...