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Study Start Up Lead
Location:
East Hanover, NJ
Description:
Job Description Summary About the role:The Study Start-Up (SSU) Lead plans and executes global SSU activities 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 Lead works collaboratively with other key Clinical Trial Team (CTT) members and leads the SSU Team (CTT sub-team) 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.Key Responsibilities:* Contributes SSU insights to the development of the trial Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader/Clinical Trial Team * Configures and ensures proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, electronic Trial Master File (eTMF), milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrolment plan, vendor management tool, site contracting and budgeting tool, ICF (Informed Consent Form) template tool, etc.) * Ensures timely collection 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 * Ensures Protocol and ICF global trial template is ready for country usage as necessary including translations * Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness* Provide proactive oversight and risk management for SSU team activities to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriate, according to Novartis standards and local and international regulations* Collaborates with GCS (Global Clinical Supply) to ensure coordination and readiness of global clinical supply* Enables country Study Start-up Managers to drive timely start-up activities from country allocation to "Ready to Enrol" within assigned trial Job Description * A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management* Fluent English, oral and written* Experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials* Contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization* Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.* Excellent communication, influencing and negotiating skills* Good knowledge of Good Clinical Practice, clinical trial set-up design and global drug development process* Data and Digital expertise. Experience working with electronic databases, clinical and/or project management planning and reporting and analytics systems Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $158,400-237,600/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. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network 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 XXXX@novartis.com call +1 (877)395-XXXX 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 $158,400.00 - $237,600.00 Skills Desired Auditing, Clinical Monitoring, Clinical Research, Clinical Trials, Data Management, Global Project Management, Health Sciences, Lifesciences
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Study Start Up Lead is a Other Jobs Study Start up Lead Job at Novartis located in East Hanover NJ. Find other listings like Study Start Up Lead by searching Oodle for Other Jobs Study Start up Lead Jobs.
Study Start Up Lead is a Other Jobs Study Start up Lead Job at Novartis located in East Hanover NJ. Find other listings like Study Start Up Lead by searching Oodle for Other Jobs Study Start up Lead Jobs.