Clinical Trials Administrator

Clinical Trials Administrator  

Location:   Leiden 

Duration: 8 months

Other: English

Imagine your next step, working for Johnson & Johnson - Janssen Biologics in Leiden as a Clinical Trials Administrator 

Position Summary:

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.

Main responsibilities

• 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

how to succeed

Knowledge, Education and Experience

• Education: at minimum a bachelor’s degree in Science, Business, Computer Science or Technology or equivalent

• At minimum 3 years of work-experience in a medium to 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.

• Experience in pharmaceutical regulations and R&D processes is a plus.

• Awareness of disclosure legislation 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.

• Proficient in Microsoft Office applications.

Preferred: 

• Experience in pharmaceutical regulations and R&D processes is a plus.

about Janssen Biologics

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/netherlands/nl

What’s in it for you?  

As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected. 

At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.  

https://www.janssen.com/netherlands/nl

benefits

This role offers a very competitive hourly rate. This contract will run for 8 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.