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Job Details


Head, Clinical Document Management Process

Management

Management

No

East Hanover, New Jersey, United States

Head, Clinical Document Management Process

Job ID

372893BR

Jan 04, 2024

USA

About the Role

100,000 and more! That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide.

But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.

The Head, Clinical Document Management Process (CDMP) group is accountable for implementing and embedding document management processes and standards aligned and harmonized across Novartis business units (across Global Drug Development (GDD), Global Medical Affairs (GMA), Novartis Institutes for Biomedical Research (NIBR) and Sandoz) enabling Novartis to meet its sponsor obligations on consistent, quality, readily accessible, inspection ready and available crucial documentation in the shape of a Trial Master File (TMF) for human subject research studies.

The Head, CDMP drives the tactical implementation of the Clinical Document Governance & Management (CDGM) strategy to meet immediate needs and evaluate future strategies to build on, ensuring Novartis is in a strong position to deliver Trial Master File (TMF) for all studies in a simple, consistent, balanced way in alignment with international regulatory expectations.

Key Responsibilities:

• Establishes and maintains Standard Operating Procedures, Business Practices and other types of written standards (e.g. specifications, guidelines, instructions) on harmonized way of generating, collecting, quality checking, approving, filing, reviewing, and archiving fit-for-purpose crucial documentation in compliance with Good Documentation Practices (GDocP) and ALCOA CCEA principles. Tracks process efficiency through metrics and spot checks, encouraging a continuous improvement mindset

• Establishes and maintains Forms, Templates and other types of written standards (e.g. checklists, user guides, process flow maps, best practices) to aid the consistent generation, collection, quality check, approval, filing, review, and archival of fit-for-purpose crucial documentation in compliance with Good Documentation Practices (GDocP) and ALCOA CCEA principles

• Establishes and embeds the TMF Reference Model governance model as the recognized Novartis backbone for crucial documents lists, taxonomy and metadata management in close collaboration with representatives of the line functions owning the documentation content

• Drives the creation of clear, effective and engaging Training Curricula for the TMF processes and their execution in collaboration with TM COE group and ensures the creation of fit-for-purpose role-based Training Curricula for TMF tasks/document management and archiving

• Continually scans and keeps sight of the evolving Regulatory landscape through proactive industry intelligence and encouraging an external network

• Provides Audit/Inspection support, maintains credibility by building trusted relationships with the internal QA functions and Health Authorities inspectors and by delivering commitments and Corrective and Preventive Action plans on time

• Establishes and maintains a sustainable User Support Model for answering process related inquiries in a timely, efficient and resolutive manner

• Sets, reviews and evaluate annual performance objectives for the CDMP group in alignment with company goals, establishes priorities and distribution of work, forecasts demand and resource needs and contributes to the CDGM budget cycles

Diversity & Inclusion / EEO

The Novartis Group of Companies 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.

Role Requirements

Essential Requirements:

• Advanced degree or combination of Bachelor’s degree in life-sciences/healthcare/pharmacy and relevant industry experience

• Minimum of 10 years of working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management

• Minimum of 3 years experience in direct people management or matrix management of project/clinical teams

• Deep understanding of drug development process, international drug approval procedures and standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g. DIA TMF reference model)

• Demonstrated success in planning and executing cross functional change projects.

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; experience establishing trusted relationships with internal and external stakeholders.

Why consider Novartis?

736 million. That’s how many lives our products touched in 2022. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Commitment to Diversity & 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 $183,200 and $274,800/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.

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 send an e-mail to [email protected] or call +1 [Register to View] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis

Network here: https://talentnetwork .

Division

Development

Business Unit

GCO GDD

Location

USA

Site

East Hanover, NJ

Company / Legal Entity

Novartis Pharmaceuticals

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No