Associate Global Trial Director (BB-D42D3)
Found in: Neuvoo IE
We're looking for a candidate to fill this position in an exciting company.
- 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.
- 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.
- 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
- Education: 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 demonstratedability 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.
calendar_today19 hours ago
work Novartis Group