Clinical Trial Manager II

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

📋 Description

• Deliver site management oversight, clinical monitoring, and central monitoring outputs, prioritizing patient safety, compliance with protocols/GCP/regulatory standards, and data integrity.

• Supervise site interactions from post-activation to site closure, encompassing patient recruitment and investigator compensation.

• Identify significant risks related to data, processes, and protocol execution, and formulate risk mitigation strategies.

• Examine the study's scope of work, budget, and protocol details; ensure that clinical project teams comprehend their contractual responsibilities.

• Recognize and escalate risks that impact timelines, quality, and budget, including activities outside of the specified scope.

• Engage in and present at essential meetings, such as Kick-Off Meetings.

• Act as a point of escalation for investigator site personnel and communicate with principal investigators and site staff via phone or in person.

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

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

• Ensure CTMS, dashboards, and other systems are properly configured and accessible, including user acceptance testing and access/audit-trail evaluations.

• Coordinate training for study teams on protocols, CRF completion, dashboards, SOPs, clinical plans, data plans, and timelines.

• Manage CRA and Central Monitor resources, site assignments, and risks related to conduct and delivery.

• Guarantee the quality and visibility of clinical monitoring, central monitoring, and site management outputs by utilizing approved systems and tracking tools.

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

• Ensure that assigned team members comprehend and adhere to monitoring strategies, CMP/SMP, and risk plans.

• Review site and central monitoring documentation, ensuring that revisions, approvals, and deliverables align with company and sponsor standards.

• Provide updates to clients, project management, and leadership regarding clinical deliverables and associated risks.

• Offer solutions to obstacles related to protocol execution and site management.

• Assist in maintaining inspection readiness for clinical trial management responsibilities.

• Supervise CRAs and Central Monitors, evaluate compliance with processes and training, identify emerging risks, and support corrective action plans.

• Aid in activities to meet data cut and database lock deadlines.

• Provide performance feedback on staff to line managers.

• May be assigned to larger, more intricate trials.

⛳️ 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 capability to work in an international setting.

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

• Preferred experience in risk-based monitoring.

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

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

• Proficient computer skills.

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

• Excellent conflict resolution skills.

• Capability to apply problem-solving techniques to address complex issues using a risk management approach.

• Critical thinking skills to identify problems, ascertain causes, and determine suitable solutions.

• Moderate travel may be necessary, approximately 20%.

🏝️ 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.

• An inclusive culture and a supportive work environment.