Trial Master File (TMF) Compliance Lead

Job Description Summary

LI-Hybrid

Location : Cambridge, MA or East Hanover, NJ

The Trial Master File (TMF) Compliance Lead will be responsible for the Translational Clinical Oncology (TCO) strategy on TMF and Document Management System (DMS) related topics to ensure compliance of global study TMFs in accordance with Novartis SOPs and ICH / GCP guidelines. The TMF Compliance Lead will represent TCO on all TMF and DMS related aspects, partnering with TMF governance, NIBR TM, with Global Drug Development (GDD), and Clinical Quality Assurance (CQA), leading TCO contribution to global workstreams and initiatives on TMF and DMS, driving change management and escalation of issues.

Job Description

Key Responsibilities :

Lead the TMF Compliance team, defining and implementing the TCO strategy for the management of study and program documentation within the Document Management Systems.

Lead all TMF QC activities for TCO in accordance with TCO portfolio and Clinical Operations study milestones as applicable per Novartis SOPs and ICH / GCP guidelines.

Liaise with partners in TMF governance, and other stakeholders to ensure alignment, and quality outcomes.

Ensure tracking and reporting of key quality indicators (KQIs) and reinforce overall compliance to TMF process and regulations.

Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations.

Ensure TCO representation and serve as TCO representative on TMF / DMS process improvement initiatives, committees, work streams and governances.

Lead the establishment and maintenance of TMF / DMS / guidance documents, best practices, and training materials for TCO Clinical Operations. Contribute to the on-boarding and training of new Clinical Operations staff.

Essential Requirements :

This position will be located at the Cambridge, MA or East Hanover, NJ site and will not have the ability to be located remotely. This position will require approximately 2 - 5% travel as defined by the business (domestic and / or international).

B.S. or advanced degree preferably in life sciences / healthcare or equivalent experience.

A minimum 10 years of relevant experience in the Pharmaceutical Industry with broad experience in TMF quality management at Global, Country or Site levels

Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations

Developed or have participated in the development of SOPs, guidance documents, work practices and tracking tools

Experience working in matrix environment and in global teams

Excellent interpersonal, problem-solving, negotiation and conflict resolution skills

Excellent organizational skills

Excellent communicator and presenter (oral and written)

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.

The pay range for this position at commencement of employment is expected to be between : $185,500 and $344,500 / year; however, while salary ranges are effective from 1 / 1 / 25 through 12 / 31 / 25, 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.

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call 1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

185,500.00 - $344,500.00

Skills Desired

Adaptive Strategy And Innovation, Clinical Research, Data Migration, Drug Development, Estimation Process, Financial Management, Influencing Skills, Interpersonal Communication Skills, Leadership, Lifesciences, Microsoft Project, Operations, Organizational And Project Design, Pmi (Project Management Institute), Pmp (Project Management Professional), Prioritization, Program Management, Project Delivery, Project Execution, Project Life Cycle, Project Planning, Project Presentation, R&D (Research And Development), Requirements Gathering, Senior Management

Salary : $185,500 - $344,500