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Job Details

Expert Transparency Manager for Clinical Trial Data




East Hanover, New Jersey, United States

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.<br><br>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.<br>1. Act as subject matter expert for Global disclosure requirements on submission- related clinical trial documentation and data sets.<br>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.<br>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.<br>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.<br>5. Anticipate and identify issues/potential resource gaps effecting preparation and delivery of Transparency submission documents across line functions; negotiate and implement solutions.<br>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.<br>7. Lead or facilitate extended Transparency Submission Team meetings to synchronize submission messages with Senior Management.<br>8. Lead, as required, Transparency Submission Team meetings, provide agenda, minutes and updates to deliverable timelines; ensure timelines are in accordance with Novartis processes.<br><br>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.