Country Study Operations Manager I

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Assist Global Study Managers and the broader study management team by overseeing assigned study components, countries, and moderately complex tasks.

• Lead local study teams across multiple studies.

• Supervise preferred CROs and/or Country Trial Managers/Site Care Partners at the country level.

• Manage timelines, budgets, risks, quality plans, startup processes, recruitment efforts, vendors, and site activation activities at the country level.

• Identify and mitigate risks associated with study startup and execution, and address any site activation escalations.

• Coordinate outreach to countries and investigators, site identification, feasibility studies, recruitment planning, and milestone reporting.

• Ensure adherence to global and local regulations, ICH GCP standards, SOPs, and other regulatory requirements.

• Facilitate communication between global and local study teams and offer protocol-level guidance.

• Ensure readiness for audits and inspections while managing relevant quality events.

• Drive the deliverables for data cleaning, TMF setup and completeness, management of investigational products and equipment, and site file reconciliation.

• Assist with local vendor or facility contracting and submissions to regulatory bodies, ethics committees, and authorities.

• Provide support for Investigator Meetings, including preparation of presentations.

• Serve as the local study team's primary contact and provide insights on country-specific risks, costs, vendors, and operational practices.

• Aid in the implementation of site technology systems and decentralized trial tools.

⛳️ Requirements

• A Bachelor's of Science or Bachelor's of Arts degree with at least 5 years of relevant operational clinical trial experience is required.

• Alternatively, a Master's of Science or Master's of Business Administration degree with a minimum of 3 years of relevant operational clinical trial experience is required.

• A scientific or technical degree is preferred.

• Proven experience in clinical research and/or as a study management/startup project manager.

• Demonstrated ability to manage country-level operational activities and/or vendors.

• Experience in managing studies and ensuring quality.

• Knowledge of Good Clinical Practice, clinical and regulatory operations, and clinical trial methodologies.

• Familiarity with working in a matrix management environment.

• Proficiency in using study and site dashboards as well as reporting tools.

• Skills in risk identification and mitigation, strategic planning, and critical path analysis.

• Strong analytical and problem-solving abilities.

• Capability to manage moderately complex processes, adapt to evolving technologies and processes, work independently, and exercise sound judgment.

• Excellent verbal and written communication skills.

• Ability to navigate within a matrix environment.

• Fluency in both written and spoken English is required.

• Willingness to work outside of core business hours as needed.

• Ability to travel as necessary for Investigator Meetings, vendor meetings, and global or departmental meetings.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and a supportive work environment.