Chaima Jemal

Clinical Trial Application Coordination Support at Sanofi (2025-05 – Present)

Follow up/monitoring of CTA operational planning activities.
Manage activities related to documentation:
Prepare necessary administrative Clinical trial application documents.
File/ensure the filing of documents in the eTMF system
Manage activities specifically related to the Clinical trials under the EU Regulation and its operational processes in the Clinical Trial Information System (CTIS)
Creation of CTA related data objects, update data fields appropriately and required by internal SOPs and policies
Contribute to data QC, and appropriate data remediation
Follow-up of submission and approval of CTA package with affiliates / partners
Run KPI reports, collating data and reporting as per oversight and governance process.

Clinical electronic documentation specialist at Sanofi (2024-05 – 2025-05)

Review/ QC check of clinical documentation (protocols, ICFs, statistical analysis plans) for completeness and accuracy.
Assists medical writers/authors to use the appropriate template as per SOPs.
Publish and check the navigation of clinical documents as per SOPs.
Use of eDMS, Vault RIM.
Collaborate with document owners (study team) to ensure the successful delivery of complete clinical document to be submitted to the health authorities.
ICH E6 (R2) Good Clinical Practice (GCP), Clinical process guide, Qualipso SOPs, ClinDoc Sharepoint

People Support Specialist at Roche (2022-01 – 2024-01)

Provide HR systems assistance, insight, and explanation, as well as advisory and administrative tasks in the areas of HR business processes and full-scale employee lifecycle events.
Create work process for the team using the information received from the stakeholders.
Handle employee processes through incoming requests via SNOW.

IT service Desk at TATA Consultancy (2021-04 – 2021-12)

Solve IT-related problems and handle customer requests.
Provide remote support through different channels such as phone, email or chat.
Support and engage customers using specific language skills (French and English).

Medical claims processor at Next Care Health -Allianz (2018-03 – 2019-10)

Review medical claims for accuracy and completeness.
Research discrepancies and determining the appropriate course of action.
Determine the best practices for submission of claims.
Request additional information, where necessary, for completion of claim processing.
Submit patient data to insurance companies and communicate with stakeholders across the healthcare industry.

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