Study Operations Manager- FSP (Dedicated to client office)

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