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About the Role

The Women's Cancer Study Group (WSG) is seeking a dedicated professional to coordinate, plan, and execute national or international clinical studies. This role involves managing timelines, milestones, and budgets, selecting and overseeing vendors, and ensuring compliance with regulatory requirements and SOPs. You will serve as the primary point of contact for all stakeholders, proactively identify risks, and contribute to quality management and process optimization.

Responsibilities

Coordinate, plan, and execute national or international clinical studies.
Plan and control timelines, milestones, and budgets.
Select, coordinate, and manage/oversee vendors.
Ensure studies are conducted in accordance with regulatory requirements and relevant SOPs.
Act as the main point of contact for all internal and external stakeholders.
Ensure no project delays through prompt and targeted communication.
Create relevant study documents or delegate and oversee these tasks.
Maintain an overall project overview and ensure all project tasks are completed on time.
Prepare and conduct project-specific training and mentor new employees.
Coordinate and manage an interdisciplinary team and exchange in regular meetings, internal and external.
Provide regular tracking and status updates.
Proactively identify risks and develop mitigation strategies.
Regularly perform quality control of the eTMF and take responsibility for it.
Further develop/create company-internal SOPs.
Support quality management and compliance.
Analyze and optimize processes and workflows.

Requirements

Several years of experience in conducting clinical studies (according to AMG / CTR) as a Clinical Project Manager or Clinical Trial Manager.
Experience with IITs (investigator-initiated trials) is an advantage.
Completed studies in a natural science / medical field or many years of professional experience.
Proven GCP knowledge (certified).
Regulatory knowledge and experience with quality standards (SOPs).
Team spirit and organizational talent.
Very good communication skills.
Stress resistance.
Accuracy, effectiveness, and diligence in daily work.
Independent, structured, and self-reliant work.
Analytical and solution-oriented thinking.
Ability to react flexibly to changing requirements.
Leadership strength and assertiveness.
Negotiation skills.
Proficient in MS Office applications.
Experience with various computer-aided systems, e.g., for data collection.
Very good to fluent German and English language skills, both written and spoken.

Skills

GCP knowledge
Regulatory knowledge
Quality standards (SOPs)
Communication skills
MS Office applications
Computer-aided systems for data collection
German language skills
English language skills

Location

Mönchengladbach
Gladenbach (near Gießen/Marburg)
Berlin

Work Type

Part-time home office possible depending on the area of responsibility
Flexible working time models

Experience Level

Several years of experience in conducting clinical studies

Education Level

Completed studies in a natural science / medical field

Benefits

Tax-free benefits in kind

About the Company

The Women's Cancer Study Group GmbH (WSG) is one of the leading academic study groups in Germany in the field of breast cancer research.
The results of our prospective randomized studies on early breast cancer have shaped 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 breast cancer patients an individually tailored, optimally tolerated, and highly effective therapy.
As an academic research institution focusing on the design, organization, and execution 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 equally good survival rates.
Join this successful team!