Clinical Trial Documentation & Records Management Lead
Vuole saperne di più su questo lavoro? Scorra verso il basso per scoprire quali competenze, esperienze e titoli di studio sono necessari.
Join to apply for the
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 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.
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.
Bachelor’s degree in life sciences or related field; advanced degree preferred.
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.
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. xlwpduy That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Clinical Trial Documentation & Records Management Lead • Roma, Lazio, IT
In a world where information is instantly accessible, hospitals remain an exception.Electronic Health Record (EHR) systems are designed to support clinical workflows, but they often fall short when... Mostra di più
Machine Learning Engineer specialized in medical imaging to develop and deploy deep learning models for radiology and pathology applications with rapid, reliable performance.You will work with a mu... Mostra di più
QuiCare is a company leader in the development and management ofbinnovative projects, integrated solutions, and services to support chronic patients and their families.QuiCare works with leading bp... Mostra di più
Global Clinical Safety Physician.The Global Patient Safety Manager is responsible for developing, managing, executing, and overseeing all aspects of the safety programmes for one (or more) pipeline... Mostra di più
Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ... Mostra di più
Role Overview /h3pWe are seeking responsible and detail-oriented professional drivers to support a long-term vehicle data collection project.Drivers will operate test vehicles equipped with advance... Mostra di più
STERIS is seeking a Quality Engineering Supervisor to lead a team of quality engineers, technicians and inspectors across multiple production lines.You will drive process and product quality improv... Mostra di più
Model validation senior specialist!.Are you ready to shape the future of capital markets? We are looking for a Model validation senior specialist to join the Model Risk LOD2 Team in Rome.This is a ... Mostra di più
Terry Soot Management Group (TSMG) is a field data collection company founded in 2017 in Europe.We collect data where automation is not possible.We count features, take pictures, make videos, recor... Mostra di più
Consumer Healthcare Business Unit Senior Director.He/She will be responsible for achieving business results, through coordination of assigned staff, coordinating with other Local and Global functio... Mostra di più
YO IT Consulting is looking for a Document Reviewer to support the training of next-generation AI systems by ensuring the accuracy of data.In this remote role, you will review structured and unstru... Mostra di più
If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!.Translational Research in Oncology (T... Mostra di più
Senior Net Revenue Management Specialist.Senior Net Revenue Management Specialist.Senior Net Revenue Management Specialist.Be among the first 25 applicants.Senior Net Revenue Management Specialist.... Mostra di più
Terry Soot Management Group (TSMG) is a field data collection company founded in 2017 in Europe.We collect data where automation is not possible.We count features, take pictures, make videos, recor... Mostra di più
Abbott Laboratories is seeking a Clinical Specialist in Rome to provide clinical and technical support for MitraClip therapy.This role involves building strong relationships with physicians and tea... Mostra di più
The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of.This position will also act as a.Quality Management Auditing system.This position is responsible for... Mostra di più
Translational Research in Oncology (TRIO) is seeking a Clinical Research Associate to join the Monitoring Resources team in a home-based role in Italy.The ideal candidate will have at least 2 years... Mostra di più
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere.For 70 years, our team has driven meaningful innovations in kid... Mostra di più
Supporting Patient Safety and Pharmacovigilance Excellence /h3 pAt Shionogi, we are committed to improving global health through innovation, collaboration and scientific excellence.As our European ... Mostra di più
A financial services company in Rome is seeking a Model validation senior specialist to validate risk models used to measure various risks.This role requires a Master's degree in a quantitative fie... Mostra di più
