Local Clinical Trial Manager – FSP

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

📋 Description

• Ensure the timely delivery of final clinical study outputs as per contracted timelines.

• Lead local clinical study teams within the country, providing matrix leadership and project management.

• Facilitate coordination between central and local study teams.

• Assist in study feasibility and site selection; take charge of site selection and oversee local study performance.

• Execute studies punctually, within budget, and meet quality expectations in compliance with protocol, regulatory, and ICH-GCP standards.

• Create and uphold country study plans, budgets, resource estimates, milestones, timelines, quality plans, and risk management plans.

• Track recruitment targets, patient recruitment timelines, data quality, and readiness for audits/inspections.

• Identify and resolve issues that may hinder country study delivery.

• Manage site supplies and oversee local inventory of supplies.

• Ensure the completeness of the trial master file, accuracy of study systems, and monitoring of risk and performance indicators.

• Develop country/site risk assessments, mitigation strategies, and escalation protocols.

• Review and approve monitoring visit reports, ensuring all monitoring activities are fulfilled.

• Oversee study budgets, site payments, vendor selection, contract negotiations, and local vendor management.

• Create study documents, plans, manuals, informed consent forms, translations, and regulatory submissions.

• Coordinate submissions and communication with regulatory bodies and ethics committees.

• Maintain up-to-date knowledge of study compounds, protocols, disease areas, local treatment guidelines, and healthcare systems.

• Assist in audits and inspections, providing responses and follow-up as necessary.

• Train in-country personnel and investigator sites, while coordinating local study meetings.

• Handle safety matters and safety report management, including SAE reporting.

• Collaborate with medical, regulatory, legal, finance, vendor, site, and other study stakeholders.

• Travel as required for the role.

⛳️ Requirements

• Bachelor's degree or equivalent relevant academic or vocational qualification.

• A minimum of 1 year of experience in a Clinical Trial Management (CTM) role.

• Previous experience in oncology is advantageous.

• Experience in site monitoring is essential.

• A combination of education, training, and/or directly related experience may be considered.

• Strong comprehension of clinical studies, drug development, sample management, and associated quality standards.

• Excellent project management abilities and capacity to operate in a matrix environment.

• Knowledge of local regulations and, if necessary, international regulations, ICH-GCP guidelines, and applicable written standards.

• Proficient English written and verbal communication skills.

• Demonstrated negotiation skills.

• Strong computer proficiency and eagerness to learn new systems.

• Willingness to travel for project-related activities as required.

• Ability to work efficiently in a remote setting.

• Capability to understand and apply digital innovations in clinical trials.

• Strong conceptual, analytical, and strategic thinking skills, including data literacy.

• Effective problem-solving and conflict-resolution abilities.

🏝️ Benefits

• Health and wellbeing support.

• Accessibility services and accommodations for job seekers with disabilities.

• Remote work arrangement.