Clinical Document Management Reference Model Manager

5+ years

Not Disclosed

Hannover

10 June 12, 2024

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, 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

Clinical Document Management Reference Model Manager

USA

About the role

Location: #LI-Hybrid ; #LI-Distance Worker

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, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.

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
Your responsibilities include, but are not limited to:
* 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, contributes to root cause analysis identification and creation/delivery of CAPAs in relation to Reference Model standards.

**The ideal location for this role is the East Hanover, NJ site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to the East Hanover, NJ site, as determined necessary by hiring manager. This position will require minimal travel as defined by the business (domestic and or international).

EEO Statement

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Role Requirements

Key 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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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.

The pay range for this position at commencement of employment is expected to be between $130,400 and $195,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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 here: https://talentnetwork.novartis.com/network

Division

Development

Business Unit

GCO GDD

Work Location

East Hanover, NJ

Company/Legal Entity

Novartis Pharmaceuticals

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

Early Talent

Clinical Document Management Reference Model Manager

USA

About the role

EEO Statement

Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Role Requirements