What we offer
Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.
As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Keyrus Life Science is looking for a Clinical Trial Coordinator to join our consulting team for a client project based in Brussels.
Your challenges will be:
Early Stage Development Support tasks:
- Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials.
- Create Essential Documents Repository.
- Assemble and track availability of all essential documentation required for study conduct.
- Provide professional presentation of study materials for investigator/vendor or country operations meetings
- Liaise with sites and in house departments to ensure appropriate regulatory follow-up
- Organization and documentation (minutes) of project team meetings where need be
Operational and project support activities, including, but not limited to:
- Update, maintain and monitor CTMS to allow accurate project management, regulatory reporting and clinical grants payments
- Follow-up/check final accountability of IMP and return or destruction as appropriate
- Possibility for SME roles: CTMS, TMF steward, SIP, CLMS, Safety reporting tracking
Support of clinical grants tasks:
Review study budgets/clinical trial agreements for consistency with study protocol
- 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
- Bachelor degree (e.g. medical assistant, or paramedical education) or relevant work experience in clinical research field
- Advanced computer skills: e.g. professional using of MS Office programs for daily business: Excel.
- Must be able to build quick basic understanding of SAP COMET, Grants Management System and eTMF (VAULT)
- Advanced communication skills (written and verbal) in French or Dutch 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
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.