FSP Local CTM - Singapore
Core
Manage clinical operational and quality aspects of low to moderate complexity oncology studies in Singapore, ensuring final clinical deliverables meet time/quality/cost expectations.
Role type
Local Clinical Trial Manager (Oncology)
Builds
Clinical trial deliverables (clean data from evaluable patients) for pharmaceutical clients
Domain
Life Sciences / Oncology Clinical Trials
Required skills
Clinical trial management, ICH GCP compliance, project management, resource management, financial acumen, regulatory submissions coordination, team leadership, data quality planning, monitoring plan development, CRF management, query resolution, ethics committee interaction
Preferred skills
Clinical Study Manager (CSM) experience, Accompanied Field Visits (AFVs) experience, bid defense presentation skills
Technologies
Outlook, Excel, Word, automated clinical systems, tracking and management tools
Responsibilities
Develop clinical tools (Monitoring Plan, Guidelines, MAP), manage clinical activity timelines and metrics, conduct monitoring visits, coordinate start-up activities and regulatory submissions, manage clinical resources and budget, lead team meetings, review monitoring visit reports, resolve CRF queries
Seniority
Mid-Senior, hands-on IC