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Clinical Trial Manager EU

4 tygodni temu

Warszawa, Mazovia, Polska Innovaderm Research Pełny etat
Clinical Trial Manager EU Job Description

We are seeking a highly skilled Clinical Trial Manager to join our team at Innovaderm Research in Poland, Spain, or Germany. As a Clinical Trial Manager, you will be responsible for the operational management and oversight of clinical investigative sites, as well as clinical monitoring deliverables of clinical trials.

Key Responsibilities:
  • Ensure timely quality deliverables and compliance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
  • Identify quality issues and trends related to site performance and clinical monitoring activities, and establish action plans to bring corrective actions.
  • Serve as a point of contact for CRAs and Lead CRAs for assigned projects, and provide mentoring/oversight of CRAs and Lead CRAs.
  • Perform site visit report review for assigned projects and track site visit report metrics to ensure compliance.
  • Contribute to the development of the Clinical Monitoring Plan, and prepare and conduct project-specific training for CRAs.
  • Develop annotated site visit reports and monitoring tools such as source data verification worksheets, and conduct quality control visits with CRAs.
  • Coordinate and lead CRA meetings, and perform co-monitoring visits with CRAs.
  • May be involved in business development activities, including client meetings, proposal defense meetings, and requests for proposals (RFPs) and requests for information (RFIs).
About Innovaderm Research

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We have a solid reputation for the quality of our research and services, and we continue to grow and expand in North America and Europe.

Requirements:
  • Bachelor's degree in a field relevant to clinical research, nursing degree, or equivalent experience.
  • At least 8 years of clinical research experience, including prior monitoring experience and at least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
  • Strong knowledge of ICH/GCP standards and applicable regulatory requirements.
  • Excellent mastery of Microsoft Office suite (Word, Excel, PowerPoint).
  • Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites, and sponsors.
  • Excellent leadership, organizational, time management, and multi-tasking skills.
  • Excellent judgement and problem-solving skills.
  • Occasional travel (up to 10% of the time), including some travel outside of the country once possible.
  • Fluent in English (excellent oral and written).
  • Experience in a CRO and in dermatology an asset.