Johnson & Johnson
Clinical Registry Administrator
Leiden, one year contract, 40h, Hybrid way of work
Johnson & Johnson Worksense is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.
We are currently recruiting a Clinical Registry Administrator
to join our contingent workforce in Janssen Biologics in Leiden for one year contract.
The Clinical Registry Administrator is a member of the enterprise-wide Clinical Registry team and supports J&J pharma and MedTech operating companies with their clinical trial disclosure obligations. As a team, located in Europe, the US, and India (service provider), we are ensuring accurate, validated and consistent clinical trial data is posted on clinical trial registries worldwide in compliance with laws and regulations.
As the clinical registry administrator
- You are responsible for the clinical trial disclosures for a subset of the J&J portfolio of clinical trials and studies
- You are responsible for the distribution and submission of data and documents for all required registries in the global disclosure plan. This includes direct submissions, but can also involve close collaboration with local country teams.
- You are a subject matter expert on clinical trial disclosure requirements
- You advise company teams with regards to registry-related questions
- You are responsible for obtaining disclosure-ready data and documents from business partners in various departments and external service providers
- You ensure that disclosure data and documents meet the J&J and external quality requirements.
- You maintain and report disclosure planning in our compliance management system and ensure it is aligned with other planning, such as in clinical trial operations and medical writing
- You maintain and coordinate with other functions changes in the disclosure planning and independently resolve items that put the disclosure planning at risk
- You maintain or facilitate maintenance of, the public register data of the trial progress as required
- You work closely with clinical teams, clinical operations and others to facilitate optimal and compliant representation of their clinical trial disclosures as needed
- You monitor and report the progress of your work in team meetings
- You work closely with clinical registry coordinators to ensure disclosure plans are carried out, and compliance and operational risks are identified and resolved
- You are able to effectively operate in a dynamic environment and interact with business partners on a regular basis. Combining business needs with functional objectives is required
To be successful in this role you have:
- Education: at minimum a bachelor’s degree in Science, Business, Computer Science or Technology or equivalent
- A minimum 3 years of work experience in a medium to the large-scale quality organization (operational quality and/or quality assurance) or equivalent in a related R&D area (clinical trials, regulatory affairs, data management, data operations, and/or statistics) is required
- Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO, and/or Biotech) is required
- Awareness of disclosure legislation is a plus
- Demonstrated competency in accurate work with clinical trials or regulatory data
- Excellent communication skills both orally and in writing with the ability to communicate effectively across departments
- Strong social skills, supporting an open, inviting, and creative environment.
- Pro-active person with analytical, problem solving, and decision-making skills for own responsibility area
- Strong planning and organizational skills
If you meet our requirements and are interested in hearing more about our Clinical Registry Administrator role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!
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