Clinical Trial Docs & Records Lead (eTMF/CTMS) – Hybrid

Chiesi Group; Italia; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Continuous training and development

Flexible working approach

Support in relocation process

Tax assistance for foreign colleagues

People-care services

Descrizione del lavoro

A global pharmaceutical company based in Parma, Italy is seeking a Clinical Trial Documentation & Records Management Lead. This role requires leadership in managing clinical documentation and records, ensuring compliance with regulatory standards, and overseeing clinical trial technologies. Candidates should have 8-10 years of experience in clinical operations and leadership skills, as well as familiarity with Veeva systems. A dynamic and supportive working environment is offered along with flexible working arrangements.

Competenze

• 8-10 years of experience in clinical operations with clinical trial technologies.
• Proven track record in managing cross-functional teams for at least 5 years.
• Familiarity with regulatory requirements and inspection readiness.

Mansioni

• Lead the Clinical Trial Documentation & Records Management Unit.
• Oversee adoption and maintenance of clinical trial technologies.
• Ensure compliance with regulatory standards and inspection readiness.

Conoscenze

Leadership

Project management

Healthcare compliance knowledge

Cross-functional team management

Formazione

Bachelor's degree in life sciences or related field

Advanced degree preferred

Strumenti

Veeva eTMF/CTMS systems

Descrizione del lavoro

A global pharmaceutical company based in Parma, Italy is seeking a Clinical Trial Documentation & Records Management Lead. This role requires leadership in managing clinical documentation and records, ensuring compliance with regulatory standards, and overseeing clinical trial technologies. Candidates should have 8-10 years of experience in clinical operations and leadership skills, as well as familiarity with Veeva systems. A dynamic and supportive working environment is offered along with flexible working arrangements.