Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
As a Clinical Registry Specialist you are a member of the enterprise wide Clinical Registry team and can support pharma, consumer and/or medical devices operating companies with their clinical trial data disclosure obligations. The team, located in the US, Europe and Asia (third party), is responsible for ensuring that accurate, validated and consistent clinical trial data is posted on clinical trial registries worldwide.
- Oversee and support regional and/or local registries for a determined section of the companies portfolio.
- Are Subject Matter Expert with regards to clinical trial disclosure requirements.
- Ensure that data quality and compliance requirements for all registries in your portfolio are met.
- Work closely together will clinical and medical teams, clinical development operations, regulatory affairs, biostats & programming, and/or local operating companies to ensure that the company meets its disclosure requirements and that the data to be disclosed is consistent across the registries and is of high quality and integrity.
- Monitor compliance of registration and results disclosures.
- Work with vendors to ensure that patients can be referred from registries to participating trial sites, as assigned.
- Keep oversight of intelligence on disclosure requirements worldwide, as assigned.
- Advise company teams with regards to registry compliance and registry-related questions.
- Support BRQC and cross-pharma/cross-segment initiatives, meetings etc. as assigned by the BRQC leadership.
- A Bachelor or Master degree in (Bio)medical Science, Bio-pharmaceutical Science, Life Science & Technology or equivalent is required
- A minimum of 3 years of experience in a medium to large scale matrix quality organization (operational quality and/or quality assurance) or equivalent time and experience in a related R&D area (clinical trials, regulatory affairs, data management, data operations and/or statistics) is preferred
- Demonstrated competency in accurate work with clinical trial or regulatory data, data management, programming, scripting or data operations
- Successful global collaborations and partnerships in a globally diverse environment
- Knowledge of procedural and records management requirements in a regulated industry is beneficial.
- Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech) is required
- Prior pharmaceutical and quality/compliance related experience is preferred
- Knowledge of the pre-clinical and clinical drug development process is beneficial
- Excellent knowledge of English is required
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.