Regional Clinical Study Manager

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

📋 Description

• Execute designated regional clinical studies with a focus on inspection readiness, adhering to established timelines and budget constraints.

• Oversee the regional clinical operations team and collaborate with external regional study partners.

• Serve as the primary escalation contact for regional study challenges and ensure alignment between regional deliverables and overarching study objectives.

• Provide progress updates on studies to senior management and the Global Clinical Study Manager.

• Represent the regional study team in internal and cross-functional Clinical Study Team meetings.

• Organize and manage assigned clinical studies from feasibility assessment through to regional closeout.

• Oversee study startup and recruitment timelines while monitoring regional progress.

• Facilitate regional trial feasibility assessments, country allocations, and site selection processes.

• Coordinate local modifications of global study documents and manage submissions to regulatory authorities and ECs/IRBs.

• Keep regional and country information up-to-date in study systems and tools.

• Collaborate with CRAs to guarantee effective site execution and review monitoring reports for approval.

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

• Contribute insights regarding regional drug inventories, local drug labels, comparator drug regulatory approvals, and reimbursement statuses.

• Oversee regional data collection, data entry, and resolution of queries.

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

• Monitor adherence to protocols, SOPs, ICH/GCP, and relevant regulations.

• Maintain regional inspection readiness and prepare sites for audits and inspections.

• Share insights and best practices to enhance study efficiency and quality.

• Select and manage regional study vendors while overseeing regional study budgets.

• Coordinate investigator fees, site payments, and reimbursement for patient travel.

• Identify regional resource requirements, establish contingency plans, and track resource utilization.

• Provide performance feedback and mentor junior team members.

⛳️ Requirements

• A Bachelor's Degree in a scientific or healthcare field is required.

• A higher degree is preferred.

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

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

• Demonstrated clinical research experience, including a proven track record as a team lead in clinical functions.

• Experience as a CRA is preferred.

• Proficient in computer skills including MS Office and project planning tools.

• Understanding of clinical trial feasibility, country allocation, site selection, study startup, recruitment, data collection, and query resolution processes.

• Familiarity with clinical research quality standards, including study protocols, SOPs, ICH/GCP, and applicable regulations.

• Capability to manage vendors, budgets, investigator fees, site payments, and patient travel reimbursement activities.

• Ability to lead regional clinical operations teams and provide mentorship to junior team members.

🏝️ Benefits

• Salary range of 281,600.00 PLN - 352,000.00 PLN.

• Full-time employment.

• Remote work.