Etmf Coordinator

eTMF Coordinator
Date: Jan 25, 2023
Department: Global Clinical Development

**Job Type**: Direct Employee
Team: R&D, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent

**Location**:
Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 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.

We are committed to embrace diversity, inclusion and equal opportunities. 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, chemical manufacturing and controls, 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) and Toronto (Canada).

Who we are looking for

Purpose

Objective of role in Global Clinical Development is:
central person to support processes, tools, and culture of the eTMF system
implementing the established processes for TMF activities and provide guidance by liaising with the study teams and relevant CRO team members
follow up with the internal stakeholders and eTMF vendor representatives on the eTMF quality issues until their resolution

Main Responsibilities

The role is responsible to adhere to eTMF SOP and other relevant TMF process supporting guidance, acting as eTMF Key-user

The role acts as eTMF Key User and is responsible for all aspects of eTMF functionalities optimisation from study beginning until study lock.
The role carries out triage of eTMF issues (i.e. processes, profiles) and escalates to provider as needed. The role is involved in Services and Management of System Crash.
The role provides support in the preparation of the study-specific RFP in relation to eTMF services, if necessary.
The role is part of the ad-hoc meeting with the Selected CRO on the eTMF and reviews the eTMF Plan for the study.
The role can act as Trainer about eTMF/TMF related processes and contributes to the development of training material (i.e. online courses).
The role is responsible for the management of CHIESI/CRO Users Requests for Access and to verify periodically the user’s status within the system and to manage CHIESI/CRO users (de)-activation.
The role is responsible for locking the eTMF.
The role supports the coordination of the migration of study-specific eTMFs from Chiesi partners (i.e. in case of acquisition or from vendors) to GCD.
The role supports GCD Clinical Operations during audits and/or regulatory Inspections in relation to TMF related matters.

Contribution to Process improvement:
The role is part of the eTMF Committee who governs standards and policies to maintain the TMF and ensure alignment with process and business requirements.
The role will help Clinical Compliance & Continuous improvement Unit to develop and keep standards and policies to maintain the TMF and ensure alignment with GCD processes. The role contributes to the changes and updates to the eTMF system interacting with the eTMF vendor and necessary activities to keep the system in a validated state.
The role helps to raise and maintain awareness across the organization of changes in the eTMF landscape, including both regulatory requirements and industry trends

Experience Required

At least 2-3 years in similar functions in an R&D environment or in a position of Clinical Trial Administrator, eTMF Specialist, Documentation System Specialist

Education

University Degree

Languages

Good knowledge of English

Technical Skills
Demonstrated proficiency with TMF Management.
Comprehensive practical knowledge of TMF processes, relat