Summary
The Clinical Operations Director is responsible for overseeing the tactical implementation of the clinical development plan for autoimmune studies. This includes managing timelines, budgets, resources, and clinical staff to ensure efficient and high-quality execution of clinical trial activities.
Requirements Bachelor's degree in a scientific field (biology, chemistry, nursing, or pharmacy preferred).At least 12 years of experience in clinical trial management, including 8 years in a leadership role and 5 years of people management.Experience in biotech or pharma industries, particularly with autoimmune indications such as Irritable Bowel Disease or Ulcerative Colitis, preferred.Expert knowledge of FDA/EMEA regulations, ICH guidelines, and GCPs.Strong time management, organizational, and problem-solving skills.Proficiency in Microsoft Outlook, Word, PowerPoint, and Project.Demonstrated ability to manage and develop team members effectively.Responsibilities Guide study teams in vendor selection and provide ongoing management oversight for clinical projects.Ensure operational feasibility of clinical plans, including forecasting time, budgets, and resources.Analyze protocols to address investigational product (IP) distribution, labeling, and regulatory requirements.Manage cross-functional and vendor deliverables, including clinical data management, site activation, patient recruitment, and tracking project timelines.Serve as the primary contact for clinical operations, ensuring effective collaboration with CROs, vendors, and trial sites.Oversee Trial Master Files (TMF) maintenance to ensure compliance with ICH-GCP and FDA standards.Monitor trial conduct through data reviews, site monitoring reports, and issue resolution.Support financial oversight by tracking invoices and reconciling changes in project scope.Lead initiatives to improve processes, develop SOPs, and provide department-level training.Manage and mentor team members, including performance evaluations and career development planning.Assist in developing and reviewing study documents, including protocols, ICFs, and study plans.Ensure effective supply chain management for investigational drug products and clinical supplies.
#J-18808-Ljbffr