Local Clinical Trial Manager

• Manage local clinical studies in the Philippines for a client
• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
• Develop clinical tools, monitoring plans, monitoring guidelines, data quality plans, and master action plans
• Ensure timely setup, organization, content, quality, and archiving of local and central Trial Master File sections
• Participate in developing CRFs, CRF guidelines, patient informed consent templates, and protocol-specific documents
• Collaborate with project managers and clinical teams; prepare, organize, and present at client, bid defense, and hand-off meetings
• Lead team meetings and implement standardized clinical monitoring processes and training
• Monitor clinical activity timelines and metrics, provide status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution
• Monitor or co-monitor clinical trials and ensure contractual obligations are met
• Conduct Accompanied Field Visits and manage project financials where applicable
• Communicate with study sites regarding protocols, patient participation, case report forms, and other study issues
• Coordinate study start-up activities and ethics committee and regulatory submissions
• Review and follow up on ethics committee questions and ensure essential document quality
• Provide input to clinical activity forecasts and manage clinical resources, assignments, delegation, and additional resource requirements
• Deliver clean data from evaluable patients within contractual timelines while meeting time, quality, cost, and profitability expectations

• Oncology experience is a must
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Good leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, communication, and attention-to-detail skills
• English language proficiency
• Familiarity with clinical monitoring practices, processes, and requirements
• Ability to evaluate workload against project budget and adjust resources
• Financial acumen and knowledge of budgeting, forecasting, and fiscal management
• Understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Computer skills using Outlook, Excel, Word, and other automated systems and computerized applications
• Ability to work effectively in a changing environment with complex/ambiguous situations
• Ability to work in a multicultural matrix organization
• Frequent travel to domestic and international site locations

• Collaboration and development opportunities
• Global team environment
• Passion, innovation, and commitment to scientific excellence
• Frequent domestic and international travel opportunities