Clinical Document Management Reference Model Manager
Company: Novartis
Experience: 5+ years
Location: Hannover, USA
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, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, 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.
About the Role:
Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards, and operations of CDM services including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, and Good Documentation Practice capability build across Novartis globally. This individual contributor role is accountable for the implementation of the governance framework to lead Novartis Clinical Document Management (CDM) Reference Model standards, including document taxonomy and metadata guidance, and to drive their adoption across the business and system configuration.
Major Responsibilities:
- Set up and maintain Novartis CDM Reference Model management framework partnering with key business and technology collaborators to ensure effective controls of crucial documents lists, taxonomy, and metadata management across multiple systems and processes.
- Lead the CDM Reference Model governance board, providing structure and process around it, facilitating effective decision-making and arbitrating across subject matter experts in multiple teams and line functions creating/owning document content.
- Support the development and delivery of strategies to increase the adoption and improvement in TMF health and document management across collaborator groups through the effective implementation of Reference standards, and contribution to filing guidance, learning material, and templates.
- Provide support in preparation for audits/inspections, contribute to root cause analysis identification and creation/delivery of CAPAs in relation to Reference Model standards.
Role Requirements:
- Bachelor's degree or equivalent and relevant industry experience.
- Minimum of 5 years working in bio-pharmaceutical clinical research and development with specific experience in clinical operations processes and clinical systems data interoperability.
- In-depth knowledge of the TMF Reference Model, EDMS reference model, and other data governance standards.
- Demonstrated success in running cross-functional initiatives, facilitating governance boards and/or leading matrixed teams.
- Strong influencing and presentation skills. Ability to communicate effectively at all levels.
- High organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
- Good negotiation, problem-solving, and conflict resolution skills.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Pay Range:
The pay range for this position at commencement of employment is expected to be between $130,400 and $195,600/year; however, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Final pay determinations will depend on various factors, including geographical location, experience level, knowledge, skills, and abilities.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network.
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