Regional Clinical Study Manager

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

📋 Description

• Responsible for delivering regional studies with inspection-ready quality, adhering to established timelines and budget constraints.

• Oversee and lead the regional clinical operations team while managing external regional partners.

• Serve as the escalation point for any regional study-related issues.

• Ensure that regional deliverables align with the overall objectives of the study.

• Conduct regional operations meetings and represent the regional study team in both internal and cross-functional discussions.

• Plan and manage assigned clinical studies from the feasibility stage through to regional closeout.

• Create, manage, and sustain regional study start-up and recruitment timelines.

• Facilitate trial feasibility, country allocation, and site selection in collaboration with relevant stakeholders.

• Provide regional insights into global study plans.

• Coordinate local adaptations of global study documents and support timely submissions to regulatory bodies and ethics committees.

• Collaborate with study start-up and regulatory teams to ensure study submissions in assigned countries.

• Maintain current regional and country information in study systems and tools.

• Work alongside Clinical Research Associates (CRAs) on site execution and review/sign off monitoring reports.

• Ensure the creation, maintenance, and quality-checking of country and site-level Trial Master Files.

• Offer input on regional drug inventories, local drug labels, comparator drug approvals, and reimbursement statuses.

• Oversee regional trial data collection, data entry, and query resolution processes.

• Assist in the planning and execution of Clinical Study Reports.

• Manage escalated site issues and ensure compliance with protocols, SOPs, ICH/GCP, and regulations.

• Guarantee regional inspection readiness and implement solutions to address study-related issues.

• Prepare sites for audits and inspections, and lead responses to findings.

• Share insights and best practices across teams.

• Drive improvements and contribute to the development of work instructions and SOPs.

• Select and manage regional study vendors during the sourcing process.

• Oversee regional study budgets.

• Coordinate investigator fees, site payments, and patient travel reimbursements.

• Identify regional resource needs and establish contingency plans.

• Monitor the utilization of regional resources.

• Provide performance feedback and mentorship to junior team members as necessary.

⛳️ Requirements

• A minimum of 4 years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO sectors.

• Demonstrated experience in clinical research, including relevant team lead experience in clinical functions.

• Prior experience as a Clinical Research Associate (CRA) is preferred.

• A Bachelor’s Degree in a scientific or healthcare-related field is required; a higher degree is preferred.

• Exceptions may be considered for candidates with relevant clinical operations experience.

• Proficiency in MS Office.

• Familiarity with project planning applications.

• Comprehensive knowledge of clinical study delivery, clinical operations, study start-up, recruitment, feasibility, country allocation, site selection, regulatory submissions, TMF management, data collection, query resolution, ICH/GCP, SOPs, and applicable regulations.

• Willingness to travel as required by business needs.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Access to an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Participation in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA)/Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.

• Reasonable accommodations for applicants with disabilities.