CTM/Sr CTM - FSP - EMEA

Clinical Trial Manager (CTM) / Senior Clinical Trial Manager (Sr CTM) – FSP – EMEA

We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr CTM) to join our dynamic team in the EMEA region. In this pivotal role, you will be responsible for driving the successful execution of clinical trials, ensuring the delivery of high-quality, clean data within the agreed timelines, budget, and regulatory standards. As a key member of our clinical operations team, you will contribute to the advancement of innovative therapies by overseeing the operational and quality aspects of assigned studies, collaborating with cross-functional teams, and maintaining compliance with ICH GCP guidelines.

Key Responsibilities

The Clinical Trial Manager will play a critical role in managing clinical trials of low to moderate complexity, ensuring all deliverables meet the sponsor’s expectations for time, quality, and cost. Your responsibilities will include:

• Study Management: Oversee the operational and quality aspects of allocated studies, ensuring compliance with ICH GCP and project-specific requirements. In some cases, you may assume the responsibilities of a Clinical Study Manager (CSM) for smaller or less complex projects.
• Clinical Tool Development: Develop essential clinical tools such as Monitoring Plans, Monitoring Guidelines, and contribute to the Master Action Plan (MAP). Ensure the timely setup, organization, and quality of Trial Master File (TMF) sections, both local and central. Participate in the design and development of Case Report Forms (CRFs), CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
• Cross-Functional Collaboration: Work closely with the clinical team, project managers, and other departments to meet project deliverables. Lead and participate in team meetings to ensure timelines, resources, interactions, and quality standards are maintained. Implement and train standardized clinical monitoring processes in alignment with corporate policies.
• Performance Monitoring and Reporting: Ensure the achievement of final clinical deliverables within the contractual timeframe by preparing and monitoring clinical activity timelines and metrics. Provide regular status updates to the project manager, review projects using tracking and management tools, and implement recovery actions as needed. Review monitoring visit reports, manage CRF collection, and resolve queries efficiently.
• Regulatory Compliance: Monitor clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, conduct Accompanied Field Visits (AFVs) and oversee project financials. Communicate with study sites regarding protocol adherence, patient participation, CRF completion, and other study-related issues. Coordinate start-up activities and ensure timely ethics committee and regulatory submissions. Review and follow up on all questions raised by ethics committees to maintain essential document quality in line with Regulatory Compliance Review standards.
• Resource Management: Provide input into the preparation of forecast estimates for clinical activities. Responsible for clinical resource management, including assignment, delegation of responsibilities, and identification of additional resource requirements as needed.

Qualifications and Experience

To excel in this role, you should possess the following qualifications and experience:

• A Bachelor’s degree or equivalent in a relevant scientific or healthcare field, along with formal academic or vocational qualifications.
• Minimum of 5+ years of relevant experience in clinical trial management, with a proven track record of delivering clinical projects within scope, on time, and within budget.
• Strong understanding of ICH GCP guidelines and regulatory requirements for clinical trials.
• Excellent communication and leadership skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Proficiency in using clinical trial management tools and tracking systems to monitor project progress and performance.
• Demonstrated ability to manage multiple priorities in a fast-paced environment while maintaining attention to detail and quality.

This position offers a unique opportunity to contribute to groundbreaking clinical research while advancing your career in a supportive and innovative environment. If you are a detail-oriented professional with a passion for clinical trial management, we invite you to apply and make a meaningful impact in the field of medical research.