You have a first experience in the Clinical Research field ? You are fluent in Dutch OR French and English ? Then this position at one of our big pharma clients may be just for you!
Job Description :
For a multinational pharmaceutical company, we are looking for a Clinical Trial Support Specialist (EN + DU/FR), responsible for delivering support to the Early Stage Development Europe Operational team. The Clinical Trial Support Specialist will be providing operational support and project support (responsible for in-house activities as well as for compliance with processes required to initiate, maintain, support and close out the early stage clinical trials managed by the department) and will carry out tasks for the support of clinical grants. The Clinical Trial Support Specialist will be supporting an average of 4-5 trails, all in different stages of Phase I.
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
- 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. Candidate must be able to build quick basic understanding of SAP COMET, Grants Management System and eTMF (VAULT)
- Fluency in English and Dutch OR French.
- 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
- Balanced salary package based on your skills and experience
- Full time postion
- Remote and office work balance (3days of homeworking)
Vacancy number: 22831