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About the Role

The role involves quality control of submitted study documents in the eTMF for completeness, timeliness, and quality, ensuring adherence to ALCOA+ criteria. You will be responsible for approving or rejecting documents, documenting decisions, and tracking corrections. Additionally, you will set up and maintain the study-specific TMF structure, monitor completeness and deadlines, generate status reports, and ensure inspection readiness. You will also contribute to TMF plans, filing conventions, SOPs, and train study teams and trial sites on filing and quality requirements.

Responsibilities

Quality control (QC review) of submitted study documents in the eTMF for completeness, timeliness, and quality, including correct filing, versioning, metadata, and adherence to ALCOA+ criteria.
Approval or justified rejection of documents, with traceable documentation of the review decision and consistent follow-up on corrections.
Setup and maintenance of the study-specific TMF structure based on the TMF Reference Model, including placeholders, milestones, and adjustments during the study.
Monitoring of completeness and deadline indicators, creation of regular TMF status reports, and active follow-up of missing or overdue documents with study teams and trial sites.
Ensuring inspection readiness throughout the study and support during audits and regulatory inspections.
Participation in TMF plan, filing conventions, and associated SOPs, as well as training of study teams and trial sites on our filing and quality requirements.

Requirements

Completed training in a medical or scientific field, a corresponding degree, or a comparable qualification.
Experience in clinical research, particularly in TMF management, or alternatively, experience in Clinical Operations (Sponsor, CRO) or Study Coordination (Trial Site).
Good knowledge of ICH-GCP guidelines and relevant regulatory requirements.
Experience with SOP-based work (Naming Convention, TMF Plan, TMF Index).
Proficient in MS Office and electronic document management systems.
Structured, meticulous, and independent work style.
Analytical thinking and interest in process optimization.
Ability to react flexibly to changing requirements.
Very good written and spoken German and English skills.
Persistence and commitment in following up on open points, even if multiple follow-ups are necessary.
Friendly and clear communication with study teams.

Skills

eTMF systems (e.g., Flexdatabases, Veeva Vault, Montrium)
CDISC TMF Reference Model
Regulatory basics: ICH E6(R3), EU Regulation 536/2014, EMA Guideline on content, management, and archiving of the Trial Master File
Oncology, particularly breast cancer
Audit or regulatory inspection support

Location

Mönchengladbach
Gladenbach (near Gießen/Marburg)
Berlin

Work Type

Home office up to three days per week
Full-time
Part-time (from 25 hours per week)

Experience Level

Experience in Clinical Research
Experience in TMF Management
Experience in Clinical Operations (Sponsor, CRO)
Experience in Study Coordination (Trial Site)
Experience with eTMF systems
Experience in Oncology
Experience supporting audits or regulatory inspections

Education Level

Completed training in a medical or scientific field
Corresponding degree
Comparable qualification

Benefits

Permanent employment contract
30 days of vacation (for a 5-day week)
Extensive training and further education opportunities
Mentoring
Flat hierarchies
Respectful, trusting, and appreciative corporate culture
Modern work environment with real scope for design

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 the guidelines 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 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 avoiding unnecessary chemotherapy while maintaining equally good survival rates.
Become part of this successful team!