Company

Biotech

CountryOperationsManager-FSP

$185–315k ~AI est. Brazil FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Biotech
Problems you'll solve

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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