Director, Clinical Operations - Neurology

Alternative Resources Company

Director, Clinical Operations - Neurology

Director, Clinical Operations – Neurology
 
This position will provide leadership, project and study management oversight to plan, conduct and/or manage all operational aspects of clinical development projects in multiple Phases supporting the indications within the neurology group. As a key stakeholder, must contribute to the overall strategic direction and vision of the clinical operations function.
 
Responsibilities
  • Responsible for building and maintaining relationships, internally and externally, thereby requiring exceptional vendor management, open, effective and proactive communication and negotiation skills.
  • Demonstrate excellent understanding of the drug development process in order to effectively manage internal and external cross-functional teams.
  • Demonstrate operational excellence to coordinate, manage and execute all clinical study related activities and must be adept at assessing complexity of work and provide "hands on" direction and support.
  • Responsible for the development and management of study budgets within defined financial goals.
  • Must have the ability to mentor clinical operations staff with their growth and development to maintain high quality staff and overall performance.
  • Contribute to the individual and team development through training initiatives and team building activities.
  • Ensures all clinical trials are executed in compliance with ICH-GCP guidelines/regulations, SOPs/SWPs and participates in the planning of quality assurance activities with accountability for the inspection readiness of assigned programs.
 
Qualifications
  • Bachelor’s degree in biological science, nursing, pharmacy with a minimum 10+ years’ experience in the pharmaceutical industry performing clinical operations functions
  • At least 5 years of clinical project management experience in managing large global clinical trials (Phases I-III) required
  • Experience in CNS highly preferred, but not required (Alzheimer’s Disease experience a plus)
  • Strong clinical study management skills
  • Requires excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills
  • Electronic data capture experience, particularly Inform, is a plus
  • Global trial experience required
  • Excellent working knowledge of ICH GCP guidelines, FDA and EMA regulations
  • Excellent written and oral communication and presentation skills
  • Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward
  • Ability to manage multiple priorities, while maintaining attention to detail is critical
  • Experience operating effectively within a matrixed environment
  • Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
  • Excellent computer skills (MS Office Suite, Project, Word, Excel, PowerPoint, and IXRS/EDC platforms)