Expert Transparency Manager for Clinical Trial Data

Employer
Novartis
Location
East Hanover, New Jersey, United States
Salary
Competitive
Closing date
Feb 7, 2023

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Discipline
Physical Sciences, Information Technology
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
Job Description

766 million lives were touched by Novartis medicines in 2021, 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.
Responsible for providing operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and datasets; to lead and direct other Transparency and Clinical team members; and to coach less
experienced Transparency Managers. To manage the logistical aspects of building the Transparency submission dossier Manage vendors and work directly with Global project teams to create and finalize clinical trial documentation and data sets for disclosure; to support and promote consistency with disclosure policies as set forth by the Clinical Disclosure Office and Data Privacy.
1. Act as subject matter expert for Global disclosure requirements on submission- related clinical trial documentation and data sets.
2. Provide leadership and matrix management of the global cross-functional Transparency Submission Team to ensure all Clinical Transparency submission documents are delivered in accordance with timelines, high quality, operational and technical procedures; report Transparency submission progress and issues with a resolution plan to Unit Head Submission Management, Regulatory Affairs and other relevant line units Heads, as needed.
3. Lead Transparency Submission planning meetings with cross-functional team members to define Transparency submission content and identify full Transparency Submission Team composition; provide meeting agenda and meeting minutes.
4. Identify all Transparency submission deliverables (including all clinical trials and reports), developing, negotiating and tracking timelines, accountabilities and responsible individuals assigned, in collaboration with Regulatory Affairs; include on Transparency Structure and maintain with real-time updates.
5. Anticipate and identify issues/potential resource gaps effecting preparation and delivery of Transparency submission documents across line functions; negotiate and implement solutions.
6. Contribute to pre-submission Health Authority Transparency In Scope Document books; applying lessons learned and potential efficiencies used successfully by other Transparency submission teams.
7. Lead or facilitate extended Transparency Submission Team meetings to synchronize submission messages with Senior Management.
8. Lead, as required, Transparency Submission Team meetings, provide agenda, minutes and updates to deliverable timelines; ensure timelines are in accordance with Novartis processes.
The pay range for this position at commencement of employment is expected to be between $136,800 and $205,200 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.

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.

Minimum Requirements

• Minimum university higher degree in life sciences/healthcare or equivalent.
• 10+ years experience in the pharmaceutical industry and broad understanding of the drug development process. Preferred
• At least 2 years experience within the clinical trial transparency or clinical trial data areas. Preferred
• Solid knowledge of the emerging principles/guidelines governing clinical trial transparency, as well as a strong understanding of the driving forces and their associated perspectives.
• Strong, detailed understanding of the steps, roles and responsibilities in generating clinical trial documentation, data sets, and submissions.
• Innovative critical thinking; detail-oriented yet pragmatic problem-solving skills.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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.
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. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

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