Ref #: 28042

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 21-Apr-2021

Description

Key responsibilities:

* The Global Clinical Trial Assistant MAO (GCTA MAO) assists with local project management
activities of a clinical trial(s) (or Medical Affairs data generation activity) in a country or countries.
* Services/deliverables include assisting with operational aspects of assigned project(s) at the
country level for end to end project management from start-up through to closeout activities.
* Further, services will range depending on the therapeutic area and project-specific requirements.
Reports to Clinical Program Leader (CPL) or designee, and partners with the Global Trial leader (GTL) to ensure overall study delivery at the country level
* Services will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
* Schedules study management team meetings for each project assigned and maintains documentation from meetings.
* Assists in management of project budgets and Affiliate spend reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
* Ensures study(s) compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring up-to- date, complete and accurate status.
* Maintains internal project specific study sites to ensure availability of all central project documents.
* Liaises with external service providers (ESP) and contract research organizations (CRO) as needed.
* Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
* With focus on quality, supports GTL, TM, CPL and Quality Assurance (QA) team with audit findings, report and CAPA management.
* Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
* Full utilization by timely and accurate time reporting.
* If applicable, region specific deliverables will be specified.


Required experience & qualifications:

* Bachelor’s degree or equivalent
* Degree in a health or science related field (nursing, drug development, biomedical sciences...)
* Previous pharma / CRO expertise, ideally as CTA or other relevant administrative profile with clinical research knowledge
* Excellent independent time management skills
* Literacy and proficiency in IT skills with appropriate software and company systems
* Excellent organizational skills, communication skills (English required, Dutch and/or French a plus)
* Eligible for fast start in Belgium