Clinical Trial Disclosure Lead (m/w/d)

Randstad is one of the world's leading HR service providers with the goal of becoming as specialized and as fair as no other company in the world of work. Through the corporate strategy "partner for talent", we find, promote, and connect specialized talents with companies – worldwide, locally, and always with high speed. We create high-performing, diverse, and agile teams and support every individual in achieving a successful career with equal opportunities.

Randstad Professional is one of the four specializations of Randstad and focuses on the placement of specialists and executives in the future-oriented sectors of IT, Engineering, Life Science, and Office.

Are you passionate about transparency in clinical research and want to ensure that global study data meets the highest regulatory standards?

We are currently looking for a Clinical Trial Disclosure Lead (m/w/d) for our pharmaceutical client in Monheim am Rhein. In this role, you will independently manage the entire process of registration and disclosure of clinical trials at the study level.

The position is to be filled within the framework of temporary employment for 18 months (with the option of permanent employment).

• Strategic Planning: Definition of the publication and registration strategy (Disclosure Strategy) as early as the concept and protocol phase, as well as during protocol amendments.
• Registration & Maintenance: Preparation, review, and submission of clinical trials in global registries (e.g., ClinicalTrials.gov, EU CTR) as well as the continuous updating of entries throughout the entire study duration.
• Results Publication: Coordination, creation, and timely submission of study results (Trial Results Disclosures).
• Compliance & Audits: Ensuring inspection readiness (Inspection Readiness) through seamless documentation and auditable evidence.
• Process Optimization: Support in data quality assurance, system maintenance, and the management of external service providers (Vendor Oversight).
• Remote: 2 days/week

• Education: Successfully completed studies (Bachelor/Master) in the field of Life Sciences, Pharmacy, Medicine, Health Economics, or a comparable qualification.
• Experience: Sound professional experience in clinical research (Clinical Research), study management (Clinical Trial Management), or the regulatory environment (Regulatory Affairs / Regulatory Operations).
• Expertise: Very good knowledge of international requirements and guidelines for the transparency of clinical trials (EU CTR, FDA requirements, ICH-GCP).
• Soft Skills: High attention to detail, strong organizational and planning skills, as well as a structured and solution-oriented way of working.
• Language Skills: Business fluent English skills in speaking and writing for collaboration in international, cross-functional teams.

• Attractive salary and long-term job security through corporate affiliation
• Up to 30 days of vacation per year
• Good chances of permanent employment with our business partners
• Tailored further training opportunities and free language courses