Clinical Trial Documentation

Clinical Trial Documentation & Records Management Lead

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Clinical Trial Documentation & Records Management Lead

role at

Chiesi Group

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas:

Discover more here

We are proud to be the largest global pharmaceutical group to be awarded

B Corp Certification , a recognition of

high social and environmental standards . We are a

reliable

company that adopts and promotes a

transparent and ethical behavior

at all levels.

We believe that the success of

Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for
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 techno