Clinical Trial Documentation & Records Lead (eTMF/CTMS)

Chiesi Farmaceutici S.p.A.; Parma; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Parma, Italy, seeks a Clinical Trial Documentation & Records Management Lead to ensure compliance with regulatory standards and manage clinical trial technologies. The ideal candidate has 8-10 years of experience in clinical operations and a robust understanding of eTMF and CTMS. This role emphasizes team leadership, cross-functional collaboration, and strategic vendor management. Join us to enhance the oversight and integrity of clinical studies while making a significant impact in the field.

Servizi

Flexible working approach

Remote working options

Support in relocation

Tax assistance service

Continuous training and development

Competenze

• 8-10 years of experience in clinical operations.
• Experience with eTMF and CTMS management.
• Proven track record in managing cross-functional teams for at least 5 years.

Mansioni

• Lead the Clinical Trial Documentation & Records Management Unit.
• Oversee compliance with regulatory standards.
• Manage strategic vendors for clinical trial technologies.
• Coordinate operations with other R&D functions.

Conoscenze

Clinical trial technologies management

Project management

Team leadership

Regulatory compliance

Problem-solving

Communication

Formazione

Bachelor's degree in scientific or business disciplines

Strumenti

Veeva eTMF/CTMS

Descrizione del lavoro

A leading pharmaceutical company in Parma, Italy, seeks a Clinical Trial Documentation & Records Management Lead to ensure compliance with regulatory standards and manage clinical trial technologies. The ideal candidate has 8-10 years of experience in clinical operations and a robust understanding of eTMF and CTMS. This role emphasizes team leadership, cross-functional collaboration, and strategic vendor management. Join us to enhance the oversight and integrity of clinical studies while making a significant impact in the field.