Country Study Manager - FSP - East Coast

Parexel•Southport, NC

About The Position

The Country Study Manager is responsible for executing study-level activities, including creating and updating trial-specific documents, overseeing vendor delivery, supporting compound training, and providing country and regional oversight of CRO operational delivery. The role supports alignment on feasibility strategy, target setting, risk reviews, and country challenges that could affect overall study delivery. The position manages study operations across areas such as sites, regulatory submissions, drug supply and use, subject enrollment, regulatory document flow, timelines, budgets, performance metrics, and data flow. It contributes to trial-level operational strategies from protocol design through the final clinical study report, supports recruitment planning and inspection readiness, and manages CRO and vendor relationships and day-to-day operations. The role also interfaces with internal stakeholders, supports onboarding and process improvement, and provides operational updates in stakeholder meetings.

Requirements

Minimum 5 years of clinical research experience gained with a CRO, biotech, or pharmaceutical company working on Phase I–IV global clinical trials.
2–3 years leading aspects of global clinical trials.
Experience working with CROs.
Excellent decision-making, analytical, and financial management skills.
Excellent leadership skills, ability to foster team productivity and cohesiveness, and ability to operate and execute with limited supervision.
Experience leading without authority in multifunctional, matrixed, and global environments.
Experience mentoring and coaching others.
Exceptional organizational skills and ability to manage competing priorities.
Strong reasoning and problem-solving abilities.
Strong project planning/management, written and verbal communication, and presentation skills.
Experience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and review.
Proficiency in MS Office Suite, including Excel, Word, and PowerPoint.
Bachelor's degree required.

Responsibilities

Manage integration of project team activities.
Manage strategic study operations, including study sites and tracking systems for regulatory submissions, drug supply and use, subject enrollment, regulatory document flow, study timelines, budget and financial information, performance metrics, and data flow.
Provide input on trial-level operational strategies for clinical trials, from protocol design through the final clinical study report.
Provide input into global subject/patient recruitment plans.
Manage aspects of CRO/vendor identification and day-to-day operational management, including setup, statement of work creation, and budget oversight.
Create and update critical trial-specific documents.
Support development of compound- and protocol-level training materials.
Review and provide input into budgets, timelines, and forecasts for assigned clinical studies.
Support inspection readiness activities, including trial-level risk identification and mitigation plans.
Participate in trial- and department-level process improvement activities as needed.
Manage relationships between study sites and vendors.
Interface with internal key stakeholders.
Support onboarding of new team members.
Attend stakeholder meetings and provide input and updates on operational activities and progress.
Travel approximately 10%.