- Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies.
- Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.)
- Responsible for global trial level document readiness (including vendor and IMP (INVESTIGATIONAL MEDICINAL PRODUCT) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation.
- Guides the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents.
- Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to East Hanover, as determined necessary by hiring manager.
- A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable.
- Fluent English, spoken and written.
- Minimum 6 years' experience in project management, in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials.
- planning, executing, reporting, and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization.
- Comprehensive experience in leading multidisciplinary teams in a complex matrix environment
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Lead, Travel Operations - East Hanover, NJ, United States - Novartis
Description
East Hanover, PreferredThe Study Start-Up (SSU) Senior Lead independently leads the planning and execution of global SSU activities for multiple medium to complex global studies of high priority to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans.
The Study Start-Up Senior Lead works collaboratively with other key Clinical Trial Team (CTT) members and leads the SSU Team (CTT sub-team / 20+ members across multiple countries) comprised of the country SSU Management, Vendor Management, Regulatory, Grants and Contracts, Translations, Document Management, Clinical Supplies, and others as needed to accelerate study, country, and site activation.
Early Planning and Team Leadership:
Hub (Europe:
acc. to new EU-CTR) as well as Health Authorities and adherence to process standards.
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:
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 let us know the nature of your request, your contact information and the job requisition number in your message:Novartis: e-mail or call: Role Requirements
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
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 $151,200 - $226,800/year; 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.
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.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Business UnitGCO GDD Work LocationEast Hanover, NJ Company/Legal EntityNovartis PharmaceuticalsFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular Shift WorkNoEarly TalentNoCountry: USA
