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Clinical Registry Administrator
CRA clinical data
JobCLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a Clinical Registry Administrator.
- BSc. or MSc.
- Clinical data
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 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 registration data of the trial progress as required
- You work closely with clinical teams, clinical operations and others facilitate optimal and compliant representation of their clinical trial disclosures as needed;
- You monitor and report 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.
ProfileWe are looking for candidates with a Bachelor’s or Master's degree in Science, Business, Computer Science or Technology and at least 3 years of work-experience in a medium to large scale quality organization (operational quality and/or quality assurance) or 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. Experience in pharmaceutical regulations and R&D processes is a plus.
- Demonstrated competency in accurate work with clinical trial 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.
- Excellent knowledge of English is required. Knowledge of an additional language is a benefit.
- Pro-active person with analytical, problem solving and decision-making skills for own responsibility area.
- Strong planning and organizational skills
- Ability to perform in a team and international organization, as well as adapt to a dynamic environment.
BenefitsContract until July or December 2023.
Hybrid working possible, 3 days on site.
Days of leave: 36
See here our other employment terms for this vacancy
Company profileJanssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.