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About the Role

The role involves monitoring clinical trials in breast cancer, ensuring accurate and timely data submission, and producing high-quality reports. You will utilize study systems, participate in team meetings, and support study centers.

Responsibilities

• Monitoring clinical trials in breast cancer and ensuring correct, complete, and timely submission of study data and documents.
• Timely creation of high-quality reports and follow-up letters from monitoring visits.
• Secure use of relevant study systems and maintenance of the CTMS.
• Participation in study team meetings and investigator meetings.
• Involvement in the selection of study centers and assessment of recruitment potential.
• Initiation of study centers, training, support, and guidance of center staff.
• Constant monitoring of recruitment performance, center performance, and quality, escalating deficiencies to the Clinical Trial Manager.
• Proactive communication with the study center and the local study team.

Requirements

• Completed training in a medical profession (e.g., medical documentation specialist, nurse, medical assistant) or a degree in a scientific/medical field.
• Experience as a clinical monitor in conducting clinical trials (ideally at least one year).
• Experience in monitoring electronic Case Report Forms and in creating monitoring reports.
• Proven GCP knowledge (certified).
• Team spirit and organizational talent, good communication skills.
• Accuracy, effectiveness, and diligence in daily work.
• Independent, structured, and self-reliant work.
• Analytical and solution-oriented thinking, as well as the ability to react flexibly to changing requirements.
• Proficient in MS Office applications.
• Experienced in regular use of various computer-aided systems, e.g., for data collection.
• Willingness to travel 2-3 days per week.
• Good to very good German and English language skills, both written and spoken.

Skills

• GCP knowledge
• MS Office applications
• Data collection systems
• Communication skills
• Organizational talent
• Analytical thinking
• Solution-oriented thinking

Location

• Mönchengladbach
• Gladenbach (near Giessen/Marburg)
• Berlin

Work Type

• Part-time home office possible depending on the area of responsibility
• Travel required

Experience Level

• At least one year of experience as a clinical monitor

Education Level

• Completed training in a medical profession
• Degree in a scientific/medical field

Benefits

• Flexible working time models
• 30 days of vacation (for a 5-day week)
• Extensive training and further education opportunities
• Attractive benefit program (including tax-free benefits in kind)

About the Company

• A successful, medium-sized company with short decision-making processes and efficient workflows.
• We are the Women's Cancer Study Group GmbH (WSG) and one of the leading academic study groups in Germany in the field of breast cancer research.
• With the results of our prospective randomized studies on early breast cancer, we have helped shape guideline and treatment practices in Germany and internationally.
• At WSG, a dedicated, highly motivated, interdisciplinary team of medical experts, scientists, data managers, statisticians, and many others works hand in hand every day to offer patients with breast cancer individually tailored, optimally tolerated, and highly effective therapy.
• As an academic research institution focusing on the design, organization, and conduct of clinical studies in the field of breast cancer, we contribute to sustainably changing guidelines and thus the treatment of every patient in Germany – for example, by foregoing unnecessary chemotherapy while maintaining good survival rates.
• Become part of this successful team!