Novartis

Clinical Document Management Reference Model Manager

Novartis

East Hanover, NJ, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Dear potential candidate,Welcome to Novartis, a global healthcare company committed to improving and extending the lives of people around the world. We are currently seeking a highly skilled and motivated individual to join our team as a Clinical Document Management Reference Model Manager.As the Clinical Document Management Reference Model Manager, you will play a crucial role in the organization and management of clinical documents in accordance with industry standards and regulations. We are looking for an individual who is detail-oriented, organized, and has a strong understanding of clinical document management processes.In this role, you will have the opportunity to work with cross-functional teams and collaborate with various stakeholders to ensure the accuracy, completeness, and consistency of clinical documents. Your expertise in the Clinical Document Management Reference Model (CDRM) will be essential in developing and implementing best practices across the organization.If you are passionate about making a difference in the healthcare industry and have a strong background in clinical document management, we encourage you to apply for this exciting opportunity. Join us in our mission to reimagine medicine and improve patient outcomes.

  1. Develop and maintain an in-depth understanding of the Clinical Document Management Reference Model (CDRM) and its role in clinical document management processes.
  2. Collaborate with cross-functional teams to ensure the accuracy, completeness, and consistency of clinical documents according to CDRM standards.
  3. Develop and implement best practices for the organization and management of clinical documents, taking into account industry regulations and guidelines.
  4. Work closely with internal and external stakeholders to ensure timely and efficient delivery of clinical documents.
  5. Monitor and track document changes, updates, and revisions to ensure compliance with CDRM standards.
  6. Identify and address any discrepancies or issues in the organization and management of clinical documents, and propose solutions to improve processes.
  7. Train and educate team members on CDRM standards and best practices for clinical document management.
  8. Keep up-to-date with industry trends and changes in regulations related to clinical document management, and make recommendations for process improvements.
  9. Collaborate with IT teams to implement and maintain document management systems and tools.
  10. Ensure all clinical documents are stored and archived in accordance with company policies and CDRM standards.
  11. Participate in audits and inspections related to clinical document management and provide necessary support and documentation.
  12. Communicate effectively with team members and stakeholders to provide updates on document management processes and any potential issues.
  13. Act as a subject matter expert on CDRM and provide guidance and support to team members as needed.
  14. Continuously review and improve processes to increase efficiency and accuracy in clinical document management.
  15. Provide regular reports and updates on document management activities to management and other relevant stakeholders.
Where is this job?
This job is located at East Hanover, NJ, USA
Job Qualifications
  • Bachelor's Or Master's Degree In Healthcare, Life Sciences, Or Related Field.

  • Minimum Of 5 Years Of Experience In Clinical Document Management Or Related Field.

  • Knowledge Of Clinical Trial Regulations And Guidelines, Including Ich-Gcp And Fda Regulations.

  • Strong Project Management Skills And Experience Managing Cross-Functional Teams.

  • Proficiency In Electronic Document Management Systems And Other Relevant Software.

Required Skills
  • Change Management

  • Project Management

  • Data Analysis

  • Quality Control

  • Record keeping

  • Document management

  • Information Security

  • Regulatory compliance

  • Training and Development

  • Workflow optimization

  • Document

  • Information Governance

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Clinical Document Management Reference Model Manager in East Hanover, NJ, USA is $90,000-$120,000 per year. This may vary depending on the specific company and individual's experience and qualifications.

Additional Information
Novartis is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJanuary 10th, 2024
Apply BeforeJune 21st, 2025
This job posting is from a verified source. 
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About Novartis

Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers surgical, ophthalmic pharmaceuticals, and vision care products. The Sandoz segment provides generic pharmaceuticals. The Vaccines & Diagnostics segment provides human vaccines and blood testing diagnostics.

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