- Delivery of high quality and timely TMF Quality Review activities for a portfolio of internalstudies.
- Drive implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.
- Responsible for timely assessment of quality and completeness of TMFs for an assigned portfolio of studies. Identifies and communicate TMF risks/trends/patterns and works with key stakeholders to define and implement pragmatic remediations.
- Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.
- Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools for TMF oversight activities in collaboration with CDM Process team and other key stakeholders
- Provides Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs.
- Identify and implement improvements to document management processes to improve quality of TMFs. May act as business lead for innovation projects to enhance TMF quality assessment.
- Supports the forecasting and tracking of TMF Quality Review resource needs including proactive identification of resources to support TMF Quality Review activities for high-risk and priority projects
- Supports definition and refinement of TMF management strategy for assigned portfolio of studies. Ensures clear expectations for TMF set up and maintenance, including contractual agreement with third parties, for outsourced studies.
- Bachelor's degree or equivalent and relevant industry experience.
- Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management.
- Demonstrated success in planning and executing cross functional 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.#GCO #CDGMWhy consider Novartis?736 million lives were touched by Novartis medicines in 2022, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
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TMF Oversight Manager - East Hanover, NJ, United States - Novartis
Description
Job Description100,000 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.
Your responsibilities include but not are limited to:
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.
Minimum requirementsThe role can be based in either India, UK, Ireland or US (East Hanover, NJ). Our selection process will prioritize associates whose roles may be changing or may be impacted. Should you be interested in a non-US listed location, please refer to requisition 363939BR to apply. Please note relocation will not be provided.What You'll bring to the role:
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously 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 $124,000 and $186,000/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 or call 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: Drug Development Business UnitGCO GDD CountryUSA Work LocationEast Hanover, NJ Company/Legal EntityNovartis PharmaceuticalsFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular Shift WorkNoEarly TalentNo
