Clinical Trial Manager II

This is a fully remote position, open to applicants in Romania, +1 more country.

📋 Description

• Oversee all facets of the development, coordination, and execution of clinical research studies from Phase 1 to Phase 4.

• Collaborate with principal investigators, research participants, client teams, investigators, and clinic operations teams.

• Organize study logistics and manage resource utilization.

• Monitor study progression against project milestones, client deliverables, and budget constraints.

• Ensure adherence to relevant regulations, protocols, Good Clinical Practice (GCP), as well as patient safety and data integrity standards.

• Supervise site interactions from activation to closeout, including recruitment and investigator payment processes.

• Identify clinical data, processes, protocol execution risks, and strategies for risk mitigation.

• Evaluate scope of work, budget, protocol content, and contractual commitments.

• Raise concerns regarding risks to timelines, quality, budget, and activities beyond the project scope.

• Participate in and present at significant meetings, including Kick-Off Meetings.

• Facilitate transitions with Study Start-Up, Patient Recruitment, Data Management, and other functional leaders.

• Create and maintain clinical study tools and templates, including Clinical Monitoring Plans.

• Ensure that Clinical Trial Management Systems (CTMS), dashboards, and other systems are properly configured and accessible, including User Acceptance Testing (UAT) and access/audit trail reviews.

• Organize initial and ongoing training for the study team.

• Manage Clinical Research Associate (CRA) and Central Monitor resourcing, site assignments, conduct, and delivery risks.

• Review monitoring documentation, dashboards, and clinical trial systems.

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

• Support inspection readiness, corrective action plans, data cuts, and database lock timelines.

• Offer performance feedback to line managers.

⛳️ Requirements

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

• Proven ability to lead and align teams toward the achievement of project milestones.

• Demonstrated experience working in an international setting.

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

• Preferred experience with risk-based monitoring methodologies.

• Understanding of financial principles related to clinical trial management and budget oversight.

• Knowledge of Good Clinical Practice (GCP)/International Council for Harmonisation (ICH) Guidelines and other relevant regulatory requirements.

• Proficient computer skills.

• Strong communication, presentation, and interpersonal skills within project teams and with sites.

• Excellent conflict resolution abilities.

• Capacity to apply problem-solving techniques to address complex issues and implement a risk management approach.

• Critical thinking skills to identify issues and determine appropriate solutions.

• Moderate travel may be necessary, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Commitment to an inclusive culture.

• Reasonable accommodations provided, when appropriate, to assist employees or applicants with disabilities.