BE - Clinical Trial Admin

Are you thinking about old problems in new ways? Passionate about making an impact? Then you belong at J&J! Johnson & Johnson is working with the latest in technology in order to change the trajectory of human health. Join us and help us improve the health across the world, every day.

Your responsibilities and your Impact:

You will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization.

You will be responsible for processing, tracking, and filing of study documents and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required.

• Supports project managers within the assigned clinical studies.

• Clinical study administrative tasks 85%

• Other Administrative Activities 15%

Key Job Activities:

• Clinical Administration Tasks - (includes (one)CTMS build and tracking, v-TMF build & upload)

• Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.

• Creation/distribution of regulatory binders & the wet-ink signed documents binder

• Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.

• Assist in providing internal communication of important clinical data and events.

• Support ongoing use of (one)CTMS by maintaining and tracking relevant activities.

• Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).

• May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs

• May be asked to assist with Device tracking and ordering if required and if applicable.

• Assistance with logistics for Investigator meetings/expert panel meetings

• Assistance with distribution of newsletter (create mailing list from (one)CTMS and routing for internal approval)

• Participates in process improvement activities related to (one)CTMS/vTMF within the department.

Other Administrative Tasks

• May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders

Education and Experience Required for Role

Essential:

• Minimum of a Bachelor Degree is required.

• Previous clinical research experience a plus.

• Requires previous administrative support experience or equivalent for at least 1 year.

• Clinical/medical background a plus.

• Requires experience and knowledge working with Microsoft office, Excel, Word and Power Point).

Demonstrated competencies in the following areas are required:

• Tracking

• Written and verbal communications

• Attention to details

• Organizational skills

Things to remember before applying for this role:

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

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that 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 in Belgium 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”.