- Location:Zaventem
#21298
Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us! Support
Support CTA/CTC for ESD Studies
Scope of work:
ESD studies assistant 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
Profile:
- Bachelor’s 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. Candidate must be able to build quick basic understanding of SAP COMET, Grants Management System and 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
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Are you interested? Apply now!
