Associate Global Trial Director
- East Hanover, NJ
Sourcing Statement You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.
With over 400 active trials in 5 hub countries, Novartis GDO Trial Management feels privileged to bring together and manage all aspects of clinical trial operations reaching around 50 000 patients worldwide.
We are a proactive learning organization and we place a lot of emphasis on collaboration and individual development. As part of this we are very committed to evaluating the latest digital technologies, always looking to transform trials and improve lives.
TM is in search of those who are passionate about applying their experience to reimagine clinical trial operations and ultimately improve the lives of our team, our organization and our patients.
We are Novartis. Join us and help us reimagine medicine.
As the leader of the cross-functional clinical trial team, leads planning and management of the assigned clinical trials end-to-end to achieve Oncology Medical Affairs (OMA), Global Medical Affairs (GMA), GMA Franchise, Global Clinical Team (GCT) and Clinical Trial Team (CTT) objectives. Oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within disease area. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial(s)
1. Lead and manage the global cross-functional CTT to ensure deliverables are met within the established timelines, budget and quality/compliance standards; accountable for representation at all internal meetings related to clinical trials; chair the routine CTT meetings, report study progress and issues/resolution plan at the Global Clinical Team (GCT). Core member of the GCT.
2. Lead the development of global clinical trial protocol(s) by translating the approved trial concept sheet(s) into efficient, high quality, executable clinical protocols: • Responsible for integrating and authoring clinical trial protocol(s) and related documents (e.g. informed consent) in collaboration with the Global Medical Director, the CTT members and the Novartis Country Pharma Organizations (CPOs) • Submit clinical trial protocol(s) to internal review board for approval; • Lead the development of scientific trial related documents (e.g. charters, scientific training material) with input of the of the Global Medical Director, and other line functions (e.g. data management, statistical analysis, etc.) as needed • Organize and participate in trial advisory committees (e.g. Data Monitoring Committee, Steering Committee). • Collaborate with the Global Medical Directors and Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol.
3. Trial planning, execution and close-out: • Ensure trial feasibility and site selection process. Where applicable in collaboration with Trial Monitoring organization. • Ensure all required documentation is provided to each participating country for Health Authority (HA) and/or Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) submissions •
Conduct investigator meetings/trainings in collaboration with the Novartis CPOs. Provide study specific training for Novartis CPOs and Regions
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Advanced degree or equivalent education/degree in life science/healthcare preferred.
Languages: Fluent English (oral and written)
• ≥5 years of operational and managerial experience in planning, executing, reporting global clinical trials in a pharmaceutical company or a contract research organization.
• Proficient communication, influencing and negotiating skills. Strong project management skills and demonstrated ability to meet timelines.
• Proven ability to work independently in a complex matrix environment (including remote or virtual team environment).
• Experience in developing effective working relationships with internal and external stakeholders
• Organizational awareness, including experience working cross-functionally and in global teams.
• Strong interpersonal, problem-solving, negotiation and conflict resolution skills.
• Established knowledge of Good Clinical Practice, clinical trial design and global drug development process.
• Proven record of managing resources
(budget and headcount).
• Good knowledge of therapeutic area preferred.
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