Job Description Summary
The ideal location for this role is East Hanover where hybrid working principles apply. A distant working arrangement may be considered in certain states for US associates who are not within a daily commutable distance (more than 50 miles one way). Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to East Hanover, as determined necessary by hiring manager.About the role:
Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up, and leverages effectively their technical and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues to the VSM while keeping Vendor Program Leads informed about risks, issues, and study progress. Oversees vendor compliance at study level.
Your Key Responsibilities:
Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM's category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Assigned responsibilities can include but are not limited to:
*Close interaction and collaboration with study team lead and study team members during study lifetime
*Review of vendor related protocol sections during protocol development
*Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion.
*Manages interface with vendors in cooperation with vendor partner functions
* Quote/proposal review in collaboration with procurement, support contract negotiations, if required
*Contributes to the development of vendor contract amendments
*Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
* Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
*Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
* Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs
Job Description
Role Requirements:
- Bachelor's degree or equivalent degree is required, with advanced degree preferred.
- 3+ years working experience and excellent knowledge of the clinical operation processes and vendor management
- * Excellent knowledge of GxP and ICH regulations
- * Very good knowledge of clinical trial design and mapping to supplier requirements
- * Thorough and technical understanding of Novartis specifications for supplier provided services
- * User Acceptance testing for eCOA and IRT
- * Site collaboration and site activation
- * Vendor management; outsourcing, contracting, sourcing, of clinical services
The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining
to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: 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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,400/$195,600 year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.
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EEO Statement:
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.
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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Salary Range
$130,400.00 - $195,600.00
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Project Management