Clinical Trial Manager I – Sponsor Dedicated

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, site management, and close-out visits either on-site or remotely.

• Assess the performance of sites and site staff, providing tailored recommendations.

• Escalate critical issues and collaborate with the project team to develop action plans.

• Ensure informed consent procedures, subject/patient confidentiality, safety, and the integrity of clinical data are maintained.

• Evaluate site processes in accordance with Clinical Monitoring/Site Management Plans.

• Perform source document reviews and validate clinical data in case report forms.

• Address queries both remotely and on-site within established timelines.

• Utilize hardware and software for reviewing and capturing clinical project data.

• Confirm compliance with electronic data capture protocols.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, administration, and documentation.

• Review and reconcile Investigator Site Files with Trial Master Files.

• Document monitoring activities through letters, trip reports, communication logs, and other project documentation.

• Assist in the strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, site status, and action items until resolution.

• Manage site-level activities and communications to achieve project objectives, deliverables, and timelines.

• Serve as a liaison with project site personnel, CRAs, and Central Monitoring Associates.

• Ensure that assigned sites and site team members receive proper training and maintain compliance.

• Participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Aid in audit readiness, preparation, and follow-up actions.

• For Real World Late Phase, provide ongoing site support throughout the study lifecycle, conduct chart abstraction and data collection, and work with sponsor affiliates, medical science liaisons, and local country staff.

⛳️ Requirements

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

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

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Willingness to travel up to 75% regularly.

• Capability to perform clinical monitoring and site management tasks both on-site and remotely.

• Understanding of local requirements for real world late phase study designs, as applicable.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition programs.

• Comprehensive total rewards program.

• A culture of total self-empowerment.

• Initiatives promoting diversity, inclusion, and a sense of belonging.