The Senior Specialist, Program Management must have an understanding and knowledge of Program Management including Phase II to IV Sponsored Clinical Studies, Managed Access Programs (Compassionate Use and Expanded Access Programs). The Sr. Specialist’s primary responsibilities will be working on Clinical Trial Agreements (CTAs), Informed Consent Reviews (ICFs) and Confidential Disclosure Agreements (CDAs), following clinical trial privacy regulations and best documentation practices.
The Senior Specialist, Program Management will work under the direction of the Director, IM Operations.
Your responsibilities include, but are not limited to:
• Contribute to study site startup process including negotiation and execution of CDAs.
• Review high volume of ICFs, based on available guidelines, focusing on some specific sections – (example: HIPAA and privacy) during initial preIRB submission, post IRB approval and amendments.
• Address post IRB comments and confirm the language used in the approved ICF is acceptable.
• Work with central IRBs to negotiate standard ICF language if necessary.
• Collect/review regulatory documentation from clinical sites during Study Start Up, obtain Verification of Document Receipt (VDR) and support trial sites as needed, during trial execution.
• Participate in startup activities with clinical trial academic centers, site management organizations and community sites.
• Facilitate site level problem solving by providing alternative or innovative solutions to meet bold study startup timelines.
• Know and apply guidelines governing the review of CTAs and negotiations with Clinical sites.
• Consult and collaborate with internal legal and privacy teams to develop alternate, approved language for CTAs.
The pay range for this position at commencement of employment is expected to be between $102,400.00 and $153,600.00 per 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.
This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. Please note that this role would not provide relocation and only local candidates will be considered.
Minimum requirements
What you’ll bring to the role:
Bachelor’s Degree (Science and/or Legal preferred).
• Previous experience a plus.
• Knowledge of GCP and Clinical trials phases. Languages N/A Technical Skills/Knowledge
• Must be proficient in Microsoft Office Suite, including Word, Excel, and Power Point. Leadership/ Organizational Skills
• Must be able to handle high volume of work in fast paced environment.
• Attention to detail.
• Excellent communication skills written and verbal.
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!
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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 [email protected] 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.
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