Clinical Trial Manager II

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

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, adherence to protocol/GCP/regulatory standards, and maintaining data integrity.

• Manage site interactions from the post-activation phase through to site closeout, which includes overseeing recruitment and investigator payments.

• Identify risks associated with clinical trials and recommend or implement mitigation strategies.

• Collaborate with the clinical project team to review the study scope, budget, protocol content, and contractual commitments.

• Highlight risks related to timelines, quality, budget, and out-of-scope issues to the project manager.

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

• Act as an escalation point for site staff and engage with principal investigators and site personnel via phone or in-person meetings.

• Work closely with Study Start-Up, Patient Recruitment, Data Management, and other functional leaders to achieve study milestones.

• Create and sustain clinical study tools and templates, such as the Clinical Monitoring Plan.

• Ensure that systems such as CTMS, dashboards, and others are properly configured, accessible, and reviewed, including User Acceptance Testing (UAT) and audit trails.

• Coordinate training for the study team on protocols, Case Report Form (CRF) completion, dashboards, Standard Operating Procedures (SOPs), plans, and timelines.

• Supervise resources, assignments, conduct, quality, and delivery risks for CRAs and Central Monitors.

• Review oversight dashboards and clinical trial systems, including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards.

• Ensure compliance with the monitoring strategy, Clinical Monitoring Plan (CMP)/Site Monitoring Plan (SMP), and risk management plans.

• Examine site and central monitoring documentation and ensure that revisions, approvals, and delivery deadlines are adhered to.

• Provide updates on client, project management, and leadership status, including risks and proposed solutions.

• Assist in preparing for inspections and developing corrective action plans.

• Supervise CRAs and Central Monitors, evaluate compliance, and support data cut and lock deadlines.

• Offer constructive feedback to line managers regarding staff performance.

⛳️ Requirements

• A 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.

• Demonstrated experience working in an international environment.

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

• Preferred experience with risk-based monitoring methodologies.

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

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

• Proficient computer skills.

• Strong communication, presentation, and interpersonal skills with project teams and site personnel.

• Excellent conflict resolution capabilities.

• Ability to apply problem-solving techniques to address complex issues and utilize a risk management approach to identify and mitigate potential risks.

• Strong critical thinking skills to determine underlying causes and suitable solutions when issues arise.

• Moderate travel may be necessary, approximately 20%.

• Equivalent experience, skills, and/or education will also be taken into consideration.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Commitment to an inclusive culture.

• Reasonable accommodations provided when applicable.