The FHI 360 is currently seeking applications from the eligible applicants for the post of Project Director based in Washington, USA.
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions.
Key Job Responsibilities
The Project Director will perform the following functions-
- Managing the organization and conduct of regulatory and non-regulatory clinical programs in compliance with Clinical Operations policies and procedures, Regulatory Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives.
- Provides Clinical Research expertise input and leadership to cross functional project teams for assigned products and indications.
- Develops and maintains strong business relationships with sponsors and key opinion leaders.
- Responsible for the overseeing and coordinating the timely development of all essential project documents including project plans, protocols, informed consent forms, case report forms, and monitoring tools.
- Selection and management of external service providers to ensure project objectives are met within required timelines and budget through vendor contracting process.
- Ensure that clinical projects are conducted in compliance with all relevant regulations and guidelines.
- Conduct quality control visits to external service providers and investigational sites to assure regulatory compliance.
- Communication with Director, Clinical Research on project status, budgetary status, critical issues and challenges.
- Develop collaborative alliances and relationships with external service providers, investigators, key opinion leaders and advisors.
- Lead the planning and implementation of sponsor and investigator meetings and advisory boards in conjunction with external service providers.
- Contribute to clinical trial reports.
- Author and contribute to scientific publications and presentations for journals and symposium.
Applicants must have-
- Bachelor’s Degree or its International Equivalent – Biology, Chemistry, Clinical Trials, Life Science, Sciences or Related Field.
- At least 10 years’ experience in clinical development gained in a CRO, Pharmaceutical or Biotechnology company.
- Excellent knowledge of the drug development process from pre-CTA/IND status through to post approval marketing studies.
- Good understanding of clinical research regulations and guidance in US, Europe and other international territories.
- Experience in third party service provider selection, contracting and management.
- Experience in managing budgets and familiarization with financial forecasting and cost accrual processes.
- Successful experience of operating in a resource constrained work environment.
- Global project management experience preferred.
- Management Experience 5+ Years.
How to Apply
Applications must be submitted through online process.
For more information, please visit FHI 360.