++ Role based in Belgium ++
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.
Major Responsibilities Approx. % of Time Required
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
? Creation/distribution of regulatory binders & the wet-ink signed
? 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
? Provide safety documentation to other functional groups in
support of safety committee meetings as requested (supporting
? 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
? 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
? Minimum of a Bachelor?s Degree is required.
? Previous clinical research experience a plus.
? Requires previous administrative support experience or equivalent for at least
? Clinical/medical background a plus.
? Requires experience and knowledge working with computer systems
(Microsoft office ? Excel, Word and Power Point).
? Demonstrated competencies in the following areas are required:
o Written and verbal communications
o Attention to details
o Organizational skills
End date: 31/12/2022 (all our contingent worker contracts are yearly contracts ending end DEC but we are definitely looking for someone who will stay in the team for multiple years). So if no significant issues, contracts will be extended for the year after.
- Agency: Achieva Group Limited
- Reference: BH-33596
Website: Achieva Group Limited
- Posted: 3rd August 2022
- Expires: 31st August 2022