Senior CTM, Internal Medicine – Dermatology, Nephrology, Cardiovascular, Women's Health, GI, Immunology, Rare Disease

This is a fully remote position, open to applicants in United Kingdom, +11 more countries.

📋 Description

• Oversee the operational and quality elements of moderate to high-complexity studies, ensuring adherence to ICH GCP standards.

• Take on roles such as regional Lead CTM, Clinical Study Manager, process enhancement, complex program management, project coordination, or broader management duties as required.

• Create clinical tools, including Monitoring Plans and Monitoring Guidelines, in alignment with the Data Quality Plan.

• Contribute to the Master Action Plan, ensuring timely organization, setup, quality, and content of sections within the Trial Master File.

• Engage in the development of CRFs, CRF guidelines, informed consent templates, and other protocol-specific documentation.

• Work collaboratively with project managers to prepare and deliver presentations at client meetings, bid defenses, and hand-off sessions.

• Facilitate clinical team meetings and coordinate with departments to uphold timelines, resources, interactions, and quality standards.

• Implement and provide training on standardized clinical monitoring procedures.

• Track clinical activity timelines and metrics, deliver project status updates, execute recovery actions, review monitoring visit reports, and oversee CRF collection and query resolution.

• Liaise with study sites concerning protocols, patient participation, case report forms, and study-related issues.

• Manage the initiation of study activities, regulatory submissions, ethics committee inquiries, and the quality of essential documents.

• Contribute to forecasts related to clinical activities.

• Oversee clinical resources, delegate tasks, assign responsibilities, and determine additional resource needs.

• May conduct Accompanied Field Visits and oversee project finances.

• May hold limited line management responsibilities for assigned North American GPHS projects.

⛳️ Requirements

• A Bachelor's degree or equivalent, along with relevant formal academic or vocational qualifications.

• A minimum of 8 years of experience demonstrating applicable knowledge, skills, and abilities.

• Consideration for equivalency through a mix of appropriate education, training, and/or directly related experience.

• Experience in one or more of the specified therapeutic areas.

• Exceptional leadership, mentoring, training, motivation, and team integration capabilities.

• Strong skills in planning, organization, interpersonal relations, problem-solving, judgment, decision-making, escalation, and risk management.

• Comprehensive understanding of change management principles and clinical monitoring practices, processes, and requirements.

• Proficient oral and written communication skills, including a strong command of the English language.

• Financial acumen, including knowledge of budgeting, forecasting, and fiscal oversight.

• In-depth familiarity with relevant regulations, including ICH/GCP and FDA guidelines.

• Proficient computer skills, including proficiency in Outlook, Excel, Word, and automated systems.

• Capacity to independently manage clinical-only studies.

🏝️ Benefits

• A global team environment.

• Opportunities for collaboration and professional development.

• A work setting focused on scientific excellence.