TMF & Clinical Operations Specialist for Impact

Excelya; Paris; Sur place; EUR 55 000 - 90 000; Plein temps

Résumé du poste

Excelya is seeking an experienced Clinical Operations professional to lead TMF/eTMF management in Paris. You will ensure inspection readiness, coordinate document flows from internal teams and CROs, and perform TMF quality checks in line with ICH-GCP guidelines.

You will also support study budgeting, invoicing, and financial tracking while maintaining CTMS and related platforms. Fluent English is required for collaboration across international teams, in a fast-paced environment.

Qualifications

• Bachelor's or Master's degree in Life Sciences or related field.
• Experience in Clinical Operations, TMF/eTMF management, or Clinical Research Admin within pharma/CRO.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Ability to coordinate multiple stakeholders (CRMs, CROs, vendors, investigators).
• Experience with financial aspects of clinical studies (budgets, POs, invoices).
• Familiarity with clinical systems and tools (CTMS, SAP, SharePoint).
• Excellent Excel and data analysis skills.
• Fluent in English.

Responsabilités

• Manage and maintain the TMF/eTMF with completeness, accuracy and inspection readiness.
• Coordinate TMF documentation activities (collection, filing, tracking, reconciliation).
• Conduct TMF quality reviews and QC checks per ICH-GCP and procedures.
• Identify and resolve missing, outdated, or incomplete study documentation.
• Oversee study document archiving per regulatory and company requirements.
• Support financial management of clinical studies (POs, invoices, budgets, commitments).
• Coordinate transparency reporting and ensure compliance with disclosure regulations.
• Provide operational support (contract management, insurance renewals, clinical supply, legal docs).
• Maintain and update CTMS/SAP/SharePoint/iCap to ensure accurate status reporting.
• Act as liaison between CRMs, CROs, vendors, and internal stakeholders for timely delivery.

Connaissances

TMF/eTMF

ICH-GCP

Stakeholder mgmt

Budget tracking

CTMS familiarity

Excel data analysis

English fluent

Formation

Bachelor's or Master's degree in Life Sciences

Outils

CTMS

SAP

SharePoint

eTMF platforms

Description du poste

Excelya is seeking an experienced Clinical Operations professional to lead TMF/eTMF management in Paris. You will ensure inspection readiness, coordinate document flows from internal teams and CROs, and perform TMF quality checks in line with ICH-GCP guidelines.

You will also support study budgeting, invoicing, and financial tracking while maintaining CTMS and related platforms. Fluent English is required for collaboration across international teams, in a fast-paced environment.