FSP Local CTM - Singapore
Core
Manage clinical operational and quality aspects of low to moderate complexity oncology studies locally in Singapore, ensuring final clean data deliverables within contractual timelines.
Role type
Senior Clinical Trial Manager (Oncology)
Builds
Clinical trial deliverables (clean data, TMF sections, monitoring plans) for pharma clients
Domain
Life Sciences / Clinical Research / Oncology
Required skills
Clinical monitoring, ICH GCP compliance, Resource management, Budgeting, Regulatory submissions, Team leadership, Data quality management, Project tracking, Query resolution, Ethics committee coordination
Preferred skills
Clinical Study Manager (CSM) experience, Accompanied Field Visits (AFVs), Bid defense preparation, Forecast estimation
Technologies
Outlook, Excel, Word, Tracking and management tools, Automated clinical systems
Responsibilities
Develop clinical tools (Monitoring Plan, Guidelines) and contribute to Master Action Plan; Coordinate start-up activities and ethics/regulatory submissions; Monitor clinical trials and manage CRF collection/query resolution; Lead team meetings and implement standardized monitoring processes; Communicate with study sites on protocol and patient participation issues; Manage clinical resources and project financials.
Seniority
Senior, hands-on IC
