Study Operations Manager- FSP (Dedicated to client office)
Primary Location: Taiwan, Remote Job ID R0000034964 Category Clinical TrialsAbout this Role
Key Accountabilities:
Operational Study Management
- Manage and oversee study activities at the regional and country level from startup through closeout
- Lead study startup processes in assigned countries or oversee pCRO responsibilities where applicable
- Support site identification and feasibility through collaboration with Site Care Partners, Country Trial Managers, or pCROs
- Provide country-level input on startup and recruitment milestones to the Global Study Manager
- Oversee pCRO and/or Country Trial Managers for assigned studies, ensuring alignment with project plans and maintaining accurate country-level timelines, budgets, and risk/quality plans
- Identify and manage deviations and risks in startup and execution; implement mitigation strategies and resolve site activation escalations
- Lead the Local Study Team, including core and ad hoc members such as Site Care Partners, Clinical Trial Assistants, Contracts Leads, Regulatory, and Medical Affairs
- Ensure compliance with global and local regulations and internal requirements
- Facilitate timely and effective communication between global and local study teams
- Provide protocol-level guidance to Local Study Team members
- Coordinate submission strategies with Site Care Partners, Regulatory, and other country-level stakeholders
- Offer local intelligence and operational insights to Global Teams
- Act as the primary contact for study-level questions within the Local Study Team
- Monitor and follow up on regional/country-level issues to ensure resolution
- Identify country-level trends and propose process improvements
- Contribute country-specific risk input to quality and monitoring plans; ensure completeness of Trial Master File (TMF) and compliance activities
- Ensure audit and inspection readiness during startup and conduct
- Manage quality events with pCRO and local teams as needed
- Coordinate site recruitment planning aligned with global and local targets
- Drive delivery of data cleaning activities for pCRO and sites
- Provide input on country-level per-subject costs, local vendor fees, and other applicable expenses
- May serve as a Subject Matter Expert or lead operational initiatives at country or regional level
- Review Pre-Trial Assessment (PTA) and Site Initiation Visit (SIV) reports completed by Site Care Partners
- Support implementation of sponsor site technology systems (e.g., SIP, CAM)
- Assist with submissions to Ethics Committees and Regulatory Authorities, including responses to queries and deficiencies
- Ensure TMF setup meets study requirements and maintain oversight of TMF and Investigator Site File (ISF) completeness
- Oversee IP/equipment/supply management including import/export licensing with support from Clinical Trial Assistants
- Support implementation of new technologies (e.g., eConsent, eISF, remote SDV/SDR, decentralized trial tools)
- Assist with identification, contracting, and management of local vendors or facilities
- Support and manage Investigator Meetings, including delivering presentations as needed
Basic Qualifications
Education and Training
- Bachelor’s degree with 5+ years of relevant experience
- Master’s degree (MBA/MS) with 3+ years of relevant experience
- Scientific or technical degree preferred
- Working knowledge of Good Clinical Practice (GCP), clinical and regulatory operations in assigned countries
- Fluency in English required
Experience
- Proven experience in clinical research and/or study management, including startup project management
- Experience managing country-level operational activities and vendors
- Familiarity with study and quality management in a matrixed environment
Skills and Technical Competencies
- Proficient in study/site dashboards and reporting tools
- Strong attention to detail and technical expertise
- Ability to manage moderately complex processes
- Effective in matrix environments
- Skilled in risk identification and mitigation
- Strategic planning, analytical thinking, and problem-solving
- Critical path analysis
- Excellent written and verbal communication skills
- Adaptability to evolving technologies and processes
- Strong interpersonal communication across internal and external stakeholders
Preferred Qualifications
Behavioral Competencies
- Comprehensive knowledge of own discipline and working knowledge of adjacent areas
- Promotes innovation and takes calculated risks to improve processes
- Capable of developing ideas and leading moderately complex projects
- Exercises sound judgment and serves as a resource for others
Work Schedule and Travel Requirements
- Travel may be required for Investigator Meetings, Vendor Kick-Offs, and departmental meetings
- May be expected to work outside core business hours to support global trials or initiative
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