You will be delivering support to the Early Stage Development Europe Operational team. He/she will be providing operational support and project support and will get familiarized with tasks for the support of clinical grants. Work will be done 1-2 days in the office, 3-4 days remote, with the possibility to change depending on the official Covid measurements.
The tasks will include, but are not limited to:
Assemble and track availability of essential documents required for study conduct
Update, maintain and monitor CTMS to allow accurate project management, regulatory reporting
Updating of clinical and study planning spreadsheets/trackers
QC essential documents, clinical milestones and other study documentation for completeness, consistency and accuracy.
Follow-up/check return or destruction of study drug
Updating of clinical and study planning databases
Review study budgets/clinical trial agreements for consistency with study protocol: ABC (anti-bribery + corruption checks) on all HCP (fact finding, workflows, tracking, renewals) + troubleshooting with compliance, technical services etc.
Clinical trial payments and payment tracking: Financial disclosure (check need, track, process letters and documentation) & Denied parties screening (DPS)
Compliance checks: disclosure agreements: Generate and track
Trial master file reconciliation of clinical grants/compliance documents
Maintenance of trackers: GMS (grants management system): enter and track payments, run reports
Execute payments in COMET (SAP), purchase orders as needed
AKKA is an international engineering consulting and R&D services company. As an innovation accelerator for its clients, AKKA supports leading industry players in the automotive, aerospace, rail, space, defense, energy and life sciences sectors throughout the life cycle of their products with cutting edge digital technologies
With more than 22.000 experts in over 25 countries, AKKA is one of the leaders in its field. In Belgium, we have close to 1000 experts active in different technical fields.
Bachelor degree (e.g. medical assistant, or paramedical education) or Master degree in health science
Advanced computer skills: e.g. professional using of MS Office programs for daily business : Excel. Candidate must be able to build quick basic understanding of SAP COMET, Grants Management System en eTMF (VAULT)
Advanced communication skills (written and verbal) in local languages and English
Understanding and knowledge of study protocols and study working documents, lab manuals, etc
Good understanding of the clinical research processes
Understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations
As an AKKA consultant, you will be:
In charge of diverse transversal and empowering projects
Supported in your career by your AKKA Manager
Actor of your training plan and your personal and professional development
Member of a dynamic and collaborative community of engineers
Benefiting from a permanent contract
Benefiting from a competitive salary packages including several extra-legal benefits.