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About the Role

The Women's Cancer Study Group (WSG) is seeking a dedicated professional to manage clinical studies from approval to CSR. This role involves overseeing milestones, managing P&L, ensuring quality and timelines, selecting trial sites and vendors, resolving conflicts, and leading a team. The position offers the opportunity to contribute to groundbreaking breast cancer research and influence treatment guidelines.

Responsibilities

Overall responsibility for all studies in your portfolio from approval to CSR.
Manage study milestones from First Patient In (FPI) to Database Lock (DB Lock), including Last Patient In (LPI) and Last Patient Last Visit (LPLV).
P&L responsibility for all studies in the portfolio; budget approvals for service providers and freelancers within the approved framework.
Ensure cost-effectiveness, adherence to deadlines, and quality of studies, including patient recruitment and monitoring.
Select trial centers based on political and medical considerations.
Select and manage qualified partners and service providers.
Resolve conflicts between sponsors, trial centers, service providers, and the team, escalating to management only when necessary.
Escalate to partners, sponsors, and internally to the COO when needed.
Lead and develop the team: capacity planning, delegation of responsibility to Project Managers, clear goals, and consistent follow-up.

Requirements

Several years of experience in conducting clinical studies (according to AMG / CTR) as a Clinical Project Manager or Clinical Trial Manager, ideally with portfolio or project responsibility.
Experience with investigator-initiated trials (IITs) is advantageous.
Completed studies in a natural science / medical field or extensive professional experience.
Proven GCP knowledge (certified).
Regulatory knowledge and experience with quality standards (SOPs).
Initial leadership experience, ideally with managing project managers.
Leadership strength and assertiveness, negotiation skills.
Strong organizational skills: manage multiple complex studies in parallel from approval to CSR.
High customer orientation: Sponsors, investigators, and study teams perceive you as a reliable partner.
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, and the ability to react flexibly to changing requirements.
Proficient in MS Office applications.
Experience with various computer-aided systems, e.g., for data collection.
Fluent German and English.

Skills

Clinical Project Management
Clinical Trial Management
GCP
SOPs
Leadership
Negotiation
Organization
Customer Orientation
Communication
MS Office
Data Collection Systems

Location

Mönchengladbach
Gladenbach (near Gießen/Marburg)
Berlin

Work Type

Hybrid (Homeoffice up to 2 days/week)

Experience Level

Several years of experience
Initial leadership experience

Education Level

Degree in a natural science / medical field
Extensive professional experience

Benefits

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

The Women's Cancer Study Group GmbH (WSG) is a leading academic study group in Germany for breast cancer research.
We have shaped the guidelines and treatment practices in Germany and internationally with the results of our prospective randomized studies on early breast cancer.
At WSG, a dedicated, highly motivated, interdisciplinary team of medical experts, natural scientists, data managers, statisticians, and many others works hand in hand every day to offer breast cancer patients 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 avoiding unnecessary chemotherapy while maintaining equally good survival rates.
Join our successful team!