Company
Biotech
CountryOperationsManager-FSP
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optimal for Manager candidates.
“Country Operations Manager - FSP. Skills: Clinical trial execution, Country-level operational planning, Stakeholder management, Budget management. Oversee end-to-end execution of clinical trials. Ensure compliance with ICH-GCP guidelines”
What You'll Achieve.
Successful planning of clinical trials; Successful execution of clinical trials; Successful delivery of clinical trials; Optimize patient enrollment; Optimize trial performance
Industry & Context.
Risk identification; Mitigation planning
What They're Looking For.
Must Have
5 years of clinical trial management experience, Experience managing outsourced studies, Experience managing CRO partnerships, Experience managing vendor oversight, Understanding of GCP, Understanding of clinical research regulations, Understanding of trial lifecycle management, Experience in feasibility assessment, Experience in site management, Experience in patient recruitment strategies, Financial acumen, Experience managing study budgets, Experience in operational forecasting, Excellent leadership skills, Excellent communication skills, Excellent stakeholder management skills
Nice to Have
Background in oncology studies, BSc/MSc/PhD academic background
What You'll Do.
Oversee end-to-end execution of clinical trials
Ensure compliance with ICH-GCP guidelines
Ensure compliance with local regulations
Ensure compliance with SOPs
Ensure compliance with protocol requirements
Lead country-level operational planning
Conduct feasibility assessments
Align internal stakeholders
Align external stakeholders
Ensure accurate forecasting
Ensure timely budget updates
Provide financial oversight
Coordinate cross-functional teams
Ensure high-quality delivery of trial activities
Ensure adherence to agreed milestones
Drive engagement strategies
Drive recruitment planning
Optimize patient enrollment
Optimize trial performance
Ensure risk identification
Ensure mitigation planning
Ensure continuous oversight of trial progress
Ensure continuous oversight of quality
Ensure continuous oversight of safety reporting
Support development of patient-facing materials
Incorporate site feedback into trial improvement strategies
Incorporate patient feedback into trial improvement strategies
Provide leadership to study teams
Provide guidance to study teams
Ensure training for study teams
Ensure alignment for study teams
Ensure consistent operational excellence
How You'll Work.
Team & Collaboration
Cross-functional teams; Global teams; Local teams
Communication Scope
Stakeholder management
Process & Methodology
Timeline development, Milestone adherence
Full Job Description
## Accountabilities In this role, you will be responsible for the successful planning, execution, and delivery of clinical trials at the country level, ensuring compliance, quality, and performance across all operational activities: Oversee the end-to-end execution of assigned clinical trials, ensuring compliance with ICH-GCP guidelines, local regulations, SOPs, and protocol requirements. Lead country-level operational planning, including feasibility assessments, timeline development, and alignment of internal and external stakeholders. Manage trial budgets, ensuring accurate forecasting, timely updates, and strong financial oversight throughout study execution. Coordinate CROs, vendors, and cross-functional teams to ensure high-quality delivery of trial activities and adherence to agreed milestones. Drive site selection, engagement strategies, and recruitment planning to optimize patient enrollment and trial performance. Ensure risk identification, mitigation planning, and continuous oversight of trial progress, quality, and safety reporting. Support the development of patient-facing materials and incorporate site and patient feedback into trial improvement strategies. Provide leadership and guidance to study teams, ensuring training, alignment, and consistent operational excellence across all partners. Requirements: The ideal candidate brings strong experience in clinical trial operations and leadership within complex, multi-stakeholder environments, particularly in outsourced or CRO-managed studies: Minimum of 5 years of clinical trial management experience within a pharmaceutical, CRO, or life sciences environment. Experience managing outsourced studies, CRO partnerships, and vendor oversight in clinical operations. Strong understanding of GCP, clinical research regulations, and trial lifecycle management. Experience in feasibility assessment, site management, and patient recruitment strategies. Background in oncology studies is highly desirable. Strong financia
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