Clinical Trial Manager

• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
• Assume Clinical Study Manager responsibilities on small and/or less complex projects when required
• Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan
• Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections
• Participate in designing and developing CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents
• Collaborate with project managers to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
• Collaborate with clinical teams and other departments to meet project deliverables
• Lead team meetings and maintain timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Archive department documents and study materials on time
• Prepare and monitor clinical activity timelines and metrics, provide project status updates, review projects with tracking tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution
• Monitor or co-monitor clinical trials to assess performance and meet contractual obligations
• Conduct Accompanied Field Visits and manage project financials in smaller regions when required
• Communicate with study sites about protocol, patient participation, case report forms, and other study-related issues
• Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions
• Ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions
• Provide input into clinical activity forecasts
• Manage clinical resources, delegate clinical responsibilities, and identify additional resource requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years
• Equivalency may consist of a combination of appropriate education, training and/or directly related experience
• Leadership, mentoring, training, team motivation, and team integration skills
• Planning and organizational skills for prioritizing workload
• Interpersonal and problem-solving skills in a multicultural matrix organization
• Ability to work effectively in changing environments with complex/ambiguous situations
• Familiarity with clinical monitoring practices, processes, and requirements
• Judgment and decision-making skills
• Effective oral and written communication skills, including English language proficiency
• Ability to evaluate workload against project budget and adjust resources accordingly
• Financial acumen and knowledge of budgeting, forecasting, and fiscal management
• Strong attention to detail
• Understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Computer skills using Outlook, Excel, Word, and other automated systems and computerized applications