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Senior CTM, Internal Medicine (Dermatology, Nephrology, Cardiovascular, Women's Health, GI, Immunology, Rare Disease)
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About this role
Role overview Lead clinical delivery for moderately to highly complex trials, working independently and sometimes taking regional lead or study management responsibilities. The role is focused on delivering reliable clinical outcomes on schedule, within quality expectations and contract scope. Applicants should bring experience in at least one of the stated therapeutic areas, including dermatology, nephrology, gastrointestinal, cardiovascular, liver, immunology, rare disease, diabetes, obesity, dyslipidemia, women’s health, rheumatology, or endocrinology.
Responsibilities - Oversee clinical operations and quality for assigned studies in accordance with ICH-GCP and project requirements. - Develop monitoring tools and contribute to study plans; ensure Trial Master File content is complete, organized, and timely. - Lead clinical team coordination, maintain timelines and quality, and train teams on standardized monitoring processes. - Track study progress and metrics, resolve delivery risks, review monitoring reports, and oversee case report form collection and query resolution. - Communicate with study sites and coordinate applicable start-up, ethics committee, and regulatory activities. - Forecast clinical work, assign and delegate responsibilities, and identify resource needs; contribute to project financial oversight.
Requirements - Bachelor’s degree or equivalent relevant academic or vocational qualification. - Experience comparable to eight or more years; an equivalent combination of education, training, and directly related experience may be considered. - Current experience in at least one of the therapeutic areas listed above. - In-depth knowledge of clinical monitoring and relevant regulations, including ICH-GCP and applicable regulatory guidance. - Strong leadership, risk management, decision-making, planning, and communication skills, including experience working across teams. - Financial and resource management capability, strong attention to detail, and confidence managing clinical-only studies independently.