Clinical Trial Manager, Home based Romania

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

📋 Description

• Design, coordinate, and execute clinical research studies from Phase 1 to Phase 4

• Work in collaboration with principal investigators, research participants, client teams, investigators, and clinic operations teams

• Organize logistics and optimize resource allocation

• Monitor study advancement against established milestones, deliverables, budgets, and relevant regulations

• Supervise site management, clinical monitoring, and central monitoring deliverables

• Manage site interactions throughout the process, from activation to closeout, which includes recruitment and investigator payments

• Recognize clinical trial risks and implement appropriate mitigation strategies

• Review the scope of work, budgets, protocols, and contractual commitments

• Escalate any risks related to timelines, quality, budgets, and scope to the project manager

• Participate in critical meetings, including Kick Off Meetings

• Act as a communication escalation point for investigator sites

• Coordinate with Study Start Up, Patient Recruitment, Data Management, and other functional leaders

• Create and maintain clinical study tools and templates, such as Clinical Monitoring Plans

• Ensure that CTMS, dashboards, and other systems are properly configured and accessible, including UAT

• Organize training for the study team on protocols, CRFs, dashboards, SOPs, plans, and timelines

• Oversee CRA and Central Monitor resourcing, assignments, conduct, and delivery risks

• Review monitoring documentation to ensure quality, compliance, and timely submission

• Provide status updates and solutions to clients, project management, and leadership

• Assist in preparing for inspections, implementing corrective action plans, and meeting data cut and database lock deadlines

• Offer performance feedback to line managers

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience

• Proven ability to lead and align teams towards achieving project milestones

• Experience in an international working environment

• Demonstrated expertise in site management and monitoring (clinical or central)

• Experience with risk-based monitoring is preferred

• Understanding of clinical trial management financial principles and budget oversight

• Familiarity with Good Clinical Practice/ICH Guidelines and other regulatory requirements

• Proficient computer skills

• Strong communication, presentation, and interpersonal abilities with project teams and sites

• Excellent conflict resolution skills

• Capability to utilize problem-solving techniques to address complex issues and implement a risk management approach

• Critical thinking skills to identify causes and develop appropriate solutions

• Approximately 20% travel may be necessary

🏝️ Benefits

• Opportunities for career development and advancement

• Supportive and engaged line management

• Technical and therapeutic area training available

• Peer recognition initiatives

• Comprehensive total rewards program

• Inclusive company culture

• Moderate travel may be required, approximately 20%