Clinical Research Manager

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

📋 Description

• Serve as the line manager for Clinical Research Associates and trial monitoring personnel.

• Plan, assign, and oversee tasks; evaluate performance and support professional growth.

• Engage in the recruitment process and allocate team members to clinical research initiatives.

• Oversee study start-up and manage trial monitoring personnel.

• Facilitate onboarding and training for new hires and supervise training programs.

• Ensure the quality of clinical work performed by assigned staff through ongoing review and assessment.

• Offer country-specific expertise regarding study start-up to study teams.

• Evaluate study start-up documents, drug labels, informed consent forms, and associated materials.

• Create and assess site-specific recruitment materials and resources.

• Collaborate with regional operations managers and clinical sites on submissions, TMF completeness, site activation, enrollment, and readiness for inspections.

• Assist in feasibility assessments, site identification, selection, and evaluation.

• Conduct accompanied CRA visits and evaluate performance.

• Review visit reports, address issues, and communicate significant risks along with proposed solutions.

• Monitor workload and quality metrics through regular analysis and reporting.

• Identify site-related problems, recommend CAPAs, recognize deficiencies, and pursue operational enhancements.

• Contribute to the Clinical Operations strategy and performance relative to key metrics.

⛳️ Requirements

• Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare field.

• At least 5–7 years of progressive experience in clinical operations within the biotech or pharmaceutical industry.

• Prior experience in clinical trials, including management or leadership roles.

• Oncology experience is highly desirable.

• Ideally, a minimum of 2 years of line management experience in the pharmaceutical or CRO sector.

• Capability to work independently and manage multiple priorities in a dynamic environment.

• Strong interpersonal and organizational skills.

• Proficient in both German and English, with excellent written and spoken abilities.

• Competent in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Willingness to travel up to 30–40% of the time.

🏝️ Benefits

• Full-time employment.

• Equal opportunity employment.