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Clinical Trial Disclosure Lead (m/f/d)GULP – experts united • Monheim
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Clinical Trial Disclosure Lead (m/f/d)

Clinical Trial Disclosure Lead (m/f/d)

GULP – experts united • Monheim
Vor 30+ Tagen
Stellenbeschreibung

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

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

This position is available via temporary employment (Arbeitnehmerüberlassung) for 18 months, with the option of contract extension.

Here's what we offer

  • Attractive salary and long-term job security through affiliation with the Group
  • Up to 30 days vacation per year
  • Good chances of being taken on by our business partners
  • Targeted training opportunities and free language courses

Your tasks

  • Strategy & Planning: Define disclosure strategies early at study concept, protocol, and amendment stages.
  • Registrations & Submissions: Prepare, review, and submit clinical trial registrations across global registries such as CTIS and ClinicalTrials.gov.

  • Lifecycle Management: Maintain accurate, up-to-date, and compliant registry records throughout the entire study lifecycle.

  • Results Disclosures: Coordinate the creation and submission of clinical trial results disclosures.

  • Compliance & Audits: Ensure full inspection readiness through precise documentation and auditable evidence.

  • Operations & Oversight: Support data quality, system maintenance, and vendor oversight activities.

  • Remote: 3 days/week or 100% remote possible

Your profile

  • Education & Experience: Degree in Life Sciences (or a related discipline) with a background in clinical research, trial management, Regulatory Affairs, or project management.

  • Technical Expertise: Knowledge of clinical trial transparency and disclosure requirements, familiarity with registries such as CTIS or ClinicalTrials.gov, and strong affinity for IT systems. (Experience at a CRO or Sponsor is a plus).

  • Languages: Fluent English (must-have); German skills are a nice-to-have.

  • Soft Skills: High attention to detail, strong organizational skills, proactive communication, and an open, collaborative mindset.

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Clinical Trial Disclosure Lead (m/f/d) • Monheim