Clinical Trial Documentation & Records Management Lead

This is what you will do

The Clinical Trial Documentation & Records Management Lead is responsible for establishing, leading, and continuously improving the Clinical Trial Documentation & Records Management Unit within Chiesi GCD. This role ensures alignment between organizational and technical requirements for clinical trial documentation and records, driving the adoption and maintenance of clinical trial technologies, including relevant processes and procedures.  The Clinical Trial Documentation & Records Management Lead drives compliance with both regulatory and business/technology (e.g. Veeva) standards and guarantees inspection readiness across the R&D Clinical trial technology ecosystem, with a focus on eTMF and CTMS modules, as well as any additional clinical modules implemented or adopted.

In addition, the Clinical Trial Documentation & Records Management Lead provides line management to the reporting roles (e.g. Clinical Trial Documentation & Records Management Specialists) and coordinate operations within GCD and others Chiesi functions (e.g. CTS, PV) for what concerns eTMF & CTMS, incl. Insp Readiness eTMF.

Additionally, the Lead plays a key role in managing strategic vendors for clinical trial technology (e.g., Veeva), overseeing contractual, business, and technical aspects, and may liaise with CROs as needed.

You will be responsible for

Leadership & Team Coordination

• Lead the Clinical Trial Documentation & Records Management Unit, overseeing direct reports (e.g. Clinical Documentation & Records Specialists) performance and development.
• Coordinate operations with other GCD/other R&D functions, such as Clinical Trial Supply (CTS), Pharmacovigilance (PV), Quality Assurance (QA), Clinical Operations Excellence, GCD Compliance, Study Teams.
• May serve as Clinical Business Administrator and eTMF Manager as defined by Veeva standards.

Clinical trial technologies Ownership & Oversight

• Oversee the adoption, set up and maintenance of clinical trial technologies, such as eTMF/CTMS instances, in collaboration with cross-functional Study Teams, other GCD/R&D functions and GICT.
• Supervise the eTMF/CTMS user accounts, training, management, systems troubleshooting and new releases adoption.
• Coordinate and ensure adequate and proactive monitoring of eTMF/CTMS metrics and KPIs, escalating issues to Study Teams or Clinical Partnership as needed.
• Ensure overall inspection readiness, including training, account setup, audit trail maintenance, and co-development of storyboards for audits and inspections.
• Manage strategic vendors for clinical trial technology (e.g., Veeva), overseeing budget, contractual, business, and technical aspects, and may liaise with CROs as needed

Process & Compliance

• Author and update Clinical trial technologies (e.g. eTMF/CTMS) related SOPs and Working Instructions in collaboration with other functions such as GCD Clinical Compliance Unit, Clinical Operations Excellence and QA.
• Plan and coordinate periodic BIMO checklist reviews with Study Teams and CROs, especially for GCD pivotal trials.
• Oversee and/or establish mechanisms for the upload and management of Chiesi documents generated internally or externally into eTMF or other repositories.

Continuous Improvement & Change Management

• Drive business transformation, digitalization, and continuous improvement across people, processes, and technology.
• Ensure the unit’s readiness for eTMF deployment and integration with CTMS and other R&D Veeva modules and/or other Clinical trial technologies.
• Address/ensure appropriate mechanisms are in place to address organizational and technical needs during system deployment and operational phases.

People & Performance Management

• Manage a multi-functional team.
• Set clear goals, KPIs, and development plans for direct reports.
• Promote a culture of accountability, collaboration, and continuous learning.

 Cross-functional Collaboration

• Collaborate with different stakeholders, internal and external, to ensure seamless execution of the tasks managed by the unit.
• Share best practices and drive synergies across GCO and GCD.

Impact & Strategic Importance

• The leadership of this unit is critical for the success of Clinical trial technologies adoption, integration and utilization to enhance studies oversight and internal alignment.
• The role is pivotal in mitigating risks of inefficiency, non-compliance, and compromised inspection readiness.

You will need to have

Bachelor's degree or equivalent in appropriate scientific or business disciplines, familiar with relevant ICH/GCP, EU and FDA guidelines and SOPs.

8-10 years of experience in clinical operations, and specifically with the adoption and management of Clinical trial technologies (e.g. eTMF and CTMS) and associated processes.

Proven track record in managing cross-functional teams, with at least 5 years of experience.

We would prefer for you to have

Excellent knowledge of healthcare compliance and other relevant guidance. Knowledge of regulatory requirements, inspection readiness, and SOP development/authoring.

Excellent knowledge of the clinical trials settings.

Excellent project management capabilities with demonstrated capability to problem solve and mediate complex issues.

Understands financial procedures, budget management.

Experience in clinical trial documentation, records management, or related areas.

Familiarity with Veeva eTMF/CTMS systems and industry best practices.

Location

Preferably based in Italy, with flexible hybrid working arrangements.