Clinical Study Administrator

Johnson & Johnson; Machelen; Sur place; EUR 21 000 - 34 000; Plein temps

Résumé du poste

Johnson & Johnson MedTech in Belgium is seeking an Administrative Support Specialist to assist clinical study staff and keep Trial Master Files in order. You will process, track, and file essential documents, and liaise with the Clinical R&D team to ensure regulatory compliance.

This contract role emphasizes attention to detail, strong communication, and proficiency with Microsoft Office and CTMS systems, with opportunities to contribute to process improvements and study operations.

Qualifications

• At least 1 year of administrative support experience.
• Clinical research experience is a plus.
• Clinical/medical background is a plus.
• Proficient with Microsoft Office (Excel, Word, PowerPoint).
• Strong tracking, written and verbal communication, and organizational skills.

Responsabilités

• Track and file study documents and manage Trial Master File.
• Create/distribute regulatory binders and the wet-ink signed documents binder.
• Assist study staff and investigators to resolve issues related to Study Files and implement corrective actions.
• Support internal communication of important clinical data and events.
• Support ongoing use of (one)CTMS by maintaining and tracking activities.
• Provide safety documentation to other functional groups for safety committee meetings.
• Assist with study supplies creation, ordering and distribution to sites.
• Assist with device tracking and ordering if required.
• Assist with Investigator meetings/expert panel meetings.
• Distribute newsletters by creating mailing lists and routing for approvals.
• Participate in process improvements for (one)CTMS/vTMF.

Description du poste

Imagine your next project advancing healthcare solutions by directly supporting clinical research activities and contributing to the smooth management of essential study operations within a global leader in medical technology.

The individual in this role 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. They will be responsible for processing, tracking, and filing study documents, and management of the Trial Master File within the clinical projects. In addition, they will administratively support clinical study staff as required and support project managers within the assigned clinical studies.

roles and responsibilities.

• 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 and 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 assist 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.
• Clinical study administrative tasks (includes (one)CTMS build and tracking, v-TMF build and upload) take up approximately 85% of time required.
• Other administrative tasks take up approximately 15% of time required, providing other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders.

how to succeed.

• Requires previous administrative support experience or equivalent for at least 1 year.
• Previous clinical research experience is a plus.
• Clinical/medical background is a plus.
• Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point).
• Demonstrated competencies in tracking.
• Demonstrated competencies in written and verbal communications.
• Demonstrated competencies in attention to details.
• Demonstrated competencies in organizational skills.

This role offers a very competitive hourly rate. This contract will run for [Insert Duration]

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 MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

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”.