Support Cta/ctc for Esd Studies

il y a 18 heures

Zaventem, Belgique Jefferson Wells Temps plein

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 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**.

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