CTM - FSP - Germany

Role overview Manage the clinical operations and quality of assigned trials, generally of low to moderate complexity, and deliver study work to agreed timelines, quality standards, and budgets. The role coordinates a clinical team, maintains study documentation, and may take on study management duties for smaller or less complex projects.

Responsibilities - Oversee trial conduct in line with ICH-GCP and project requirements; monitor progress and take recovery action when needed. - Create or contribute to monitoring plans and other clinical tools, and maintain accurate local and central Trial Master File sections. - Coordinate team communications and meetings, align resources and timelines, and train staff on study monitoring processes. - Track clinical milestones and metrics, review monitoring visit reports, and support case report form collection and query resolution. - Coordinate site communications and, where assigned, study start-up, ethics committee interactions, and regulatory submissions. - Contribute to forecasts, manage clinical resource assignments, and support project and client meetings.

Requirements - Bachelor’s degree or equivalent relevant academic or vocational qualification. - Experience comparable to five or more years in relevant work; an equivalent combination of education, training, and directly related experience may be considered. - Strong understanding of clinical monitoring practices and applicable requirements, including ICH-GCP and relevant regulatory guidance. - Leadership, planning, organization, and communication skills, including the ability to mentor and coordinate multicultural teams. - Sound judgment, attention to detail, and ability to manage changing or ambiguous situations. - Budgeting and forecasting knowledge, with the ability to align workload and resources to project budgets; effective use of common office applications.

Benefits and work setup The role is described as office-based and involves frequent travel to study sites, both within the country and internationally.