Global Clinical Trial Manager II, Solid CRA Background

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Oversee site management, clinical monitoring, and deliverables related to central monitoring.

• Ensure compliance with patient safety, protocols, Good Clinical Practice (GCP), regulatory standards, and data integrity.

• Manage site interactions from activation to closeout, encompassing recruitment and investigator compensation.

• Identify and mitigate risks associated with clinical trials.

• Review the study's scope, budget, protocol details, and contractual obligations.

• Escalate risks pertaining to timelines, quality, budget, and scope to the project manager.

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

• Act as a point of escalation for communications with investigator sites and assist with site observations or conflict resolution.

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

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

• Ensure that the Clinical Trial Management System (CTMS), dashboards, and other systems are properly configured, tested, and maintained.

• Coordinate study team training on protocols, Case Report Forms (CRFs), dashboards, standard operating procedures (SOPs), plans, and timelines.

• Oversee the resource allocation, assignments, conduct, and delivery risks for Clinical Research Associates (CRAs) and Central Monitors.

• Review monitoring documentation, dashboards, and clinical trial systems for quality, compliance, and timely execution.

• Ensure adherence to monitoring strategies, Clinical Monitoring Plans (CMP)/Site Monitoring Plans (SMP), and risk plans.

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

• Support activities related to inspection readiness, corrective action plans, data cuts, and database lock.

• Supervise CRAs and Central Monitors and deliver performance feedback to line managers.

⛳️ 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.

• Ability to operate within an international context.

• Expertise in site management and clinical or central monitoring.

• Experience with risk-based monitoring is preferred.

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

• Knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) Guidelines, and other relevant regulatory requirements.

• Proficient in computer skills.

• Strong communication, presentation, and interpersonal skills.

• Excellent conflict resolution abilities.

• Capacity to apply problem-solving techniques to navigate complex issues using a risk-management approach.

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

• Must be fully home-based in the UK, Poland, Spain, or Bulgaria.

• 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.

• An inclusive workplace culture.

• Moderate travel opportunities (approximately 20%).