Ref #: 28042

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 26-May-2021


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

Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.