eTMF & Data Archiving Manager

Date:  23-Jan-2023
Department:  Global Clinical Development
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Job Type:  Direct Employee
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.

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

  • To ensure data management and statistics trial documentation is managed according to internal standards and regulatory requirements.
  • To oversee activities to ensure TMF documentation is published in a timely manner and with high quality in order to maintain TMF in an inspection and audit readiness.
  • To lead the Documentation and Data Archiving team providing subject matter expertise and guidance to team members.
  • To ensure providers match performance expectations.
  • To promote optimal use of tools and metrics related to documentation management.

Main Responsibilities

  • To lead the documentation and data archiving team, recruiting, mentoring and developing the team.
  • To train DM/STAT CRO on Chiesi standards and TMF related activity.
  • To monitor TMF related activities using metrics to evaluate status and gaps to ensure quality and timelines and evaluate corrective actions.
  • To support team members in the TMF plan activities and quality checks.
  • To participate to audit and inspection to TMF.
  • To perform regular checks on data archiving activities to ensure timelines are respected.
  • To contribute to eTMF process improvement and internal system development.

Experience Required

At least 8 years of experience in a similar job in the industry or CRO.

Education

Scientific degree.

Technical Skills

  • Knowledge of drug development process.
  • Solid knowledge of clinical data management and statistical process and related documentation, standards and tools.
  • Strong knowledge of international standards for Trial Master File (TMF Reference Model).
  • Knowledge of ICH GCP and regulatory requirements with specific reference to data integrity, data archiving and document management.
  • Good knowledge of SAS System.
  • Knowledge of international data standards (CDISC) and regulatory requirements for data submission.
  • Project and budget management.

Languages

Fluent English.

Soft Skills

  • Communication skills
  • Planning and organizational skills
  • Problem solving
  • Team working
  • Time management

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. 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.

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