Clinical Study Administrator

Clinical Study Administrator

Location: Diegem

Working mode: Hybrid

Language requirements: Dutch and English

Duration: Until the end of 2024 (opportunity for a contract extension)

Hours: 40 hours per week

Pay rate range: Competitive hourly rate

Imagine your next project as Clinical Study Administrator. This individual 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.

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.

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 & 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/v-TMF within the department.

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

how to succeed

Education

• Minimum of a Bachelor’s Degree is required.

• Language requirements: English and Dutch

Experience

• Previous clinical research experience a must.

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

• Clinical/medical background a must.

Knowledge

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

benefits

This role offers a very competitive hourly rate. This contract will run until the end of 2024 and has a strong chance of extension. 

you are welcome here

Cerenovus 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 Cerenovus

Cerenovus is part of Johnson & Johnson MedTech and an emerging leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. At Cerenovus we offer a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. Contribute to the next healthcare breakthrough with your next project at Cerenovus. 

https://www.jnjmedtech.com/en-US/companies/cerenovus

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. The pay rate for this role will depend on how you are paid. Options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (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 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”.