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Job Details


Clinical Document Management Capability Team Lead

Management

Management

No

East Hanover, New Jersey, United States

Clinical Document Management Capability Team Lead

Job ID

386082BR

Jan 18, 2024

USA

About the Role

Location: Hybrid

\#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 role will be accountable for leading a team responsible for ensuring effective planning, delivery and oversight of capability and learning activities in relation to clinical document management processes and systems across the Novartis organization.

Your Key Responsibilities:

• Lead a team delivering capability and learning activities related to the delivery of capability and learning services to help drive adoption of Trial Master File (TMF) and good documentation practices across the business.

• Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to improve clinical document management capability and learning at Novartis.

• Act as CDGM capability and learning contact for key partners, collaborating with them to improve clinical documentation process, systems and capabilities across the organization.

• Delivers excellence in service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.

• Provide robust oversight of 3rd party vendor activities including monitoring balanced performance against SLAs.

Lead or contribute to cross functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring deliverables are achieved in line with agreed timeframes and budget.

• Embeds a risk-based mindset across the team and in service delivery, ensuring identification, evaluation and management of risks, including mitigation activities.

• Set priorities, manage schedules and develop robust resourcing model to support timely delivery of TMF services.

• Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time. Leads team, recruits, retains, handles and develops associates through mentor and feedback, talent reviews and other available Novartis resources and tools, and champions a safe environment for team dialogue and growth.

**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).

Diversity & Inclusion / EEO

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:

Role Requirements

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

• Minimum of 8 years of working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organization) 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).

• Experience with eLearning systems and tools for GCP applications, good understanding of trial management and clinical systems

• Experience of leading change management initiatives and capability build programs

Desire Experience:

• Demonstrated success in planning and performing cross functional projects with strong influencing and presentation skills. Ability to communicate effectively at all levels.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits & Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion: 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.

Compensation & Benefits Summary: The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000/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: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about

suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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