Clinical Trial Manager II

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

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables with an emphasis on patient safety, adherence to protocols, GCP, regulatory compliance, and data integrity.

• Manages site interactions from activation through to the closeout phase.

• May identify critical data and processes, assess protocol execution risks, and implement risk mitigation strategies.

• Reviews the study's scope of work, budget, and protocol details while ensuring the clinical project team is informed of contractual obligations and parameters.

• Utilizes previous clinical experience, operational data, metrics, and reports to pinpoint risks associated with clinical trial management deliverables.

• Alerts the project manager to any risks concerning clinical trial management deliverables and any activities or requests that exceed the contracted scope.

• Applies strategic thinking and problem-solving abilities to suggest and execute risk mitigation strategies.

• Engages in and presents during key meetings, such as the Kick-Off Meeting.

• Acts as an escalation point for communications with investigator site personnel.

• Works collaboratively with other functional leaders to coordinate transitions and achieve targeted study milestones.

• Reviews and provides input on other functional plans relevant to clinical trial management activities.

• Responsible for the creation and continuous maintenance of clinical study tools and templates.

• Ensures that systems are established and accessible for the clinical team, including overseeing user acceptance testing as necessary.

• Conducts access and audit trail reviews as required.

• Coordinates both initial and ongoing training for the study team regarding protocol specifics, Case Report Form completion, dashboards, clinical plans, and guidelines.

• Manages resource allocations for CRAs and Central Monitors, site assignments, and the conduct of study team members.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables.

• Reviews project oversight dashboards and other clinical trial systems to monitor site and patient activities.

⛳️ Requirements

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

• Proven ability to lead and align teams in achieving project milestones.

• Experience working effectively in an international environment.

• Demonstrated expertise in site management and monitoring, whether clinical or central.

• Preferred experience in risk-based monitoring.

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

• Must possess proficient computer skills.

• Strong conflict resolution capabilities.

• Ability to apply problem-solving techniques to address complex issues.

• Demonstrates critical thinking to identify the causes and appropriate solutions for issues.

• Moderate travel may be necessary, approximately 20%.

🏝️ Benefits

• We are dedicated to the development of our employees through career advancement opportunities.

• Supportive and engaged line management.

• Training in technical aspects and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Committed to fostering an inclusive culture where you can genuinely be yourself.