identification of medicinal product (idmp) implementation support specialist - 2349.

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 studyconduct.
• Provide professional presentation of study materials for investigator/vendor or countryoperations 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. 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

Consultancy

We offer an attractive salary with extra-legal advantages : 

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car 
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc

A rate as freelance is also possible