Area Clinical Operations Lead

3 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**: 15 Apr 2024
**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
- Responsible to ensure the connection between the high level expertise within different studies and the wider view of the program. Early, late phase and RWE components need to be connected and to become functional part of a bigger picture. Late phase global study coordination, early phase study management and interaction with Health Authorities represent key assets for the position.
- Accountable for coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi goals and medical/scientific standards.
- Accountable to maintain and respect program budget
- Line management of Clinical Project Managers

Main Responsibilities
- To ensure the connection between the high level expertise within single study conduction to the wider view of the program. Early, late phase and RWE components need to be connected and to become functional part of a bigger picture.
- To supervise and oversee the entire value chain of Clinical Operations within the assigned program
- To ensure that GANTT master on the clinical operations activities within an assigned program is set up
- Late phase global study coordination, early phase study management and interaction with Health Authorities experience represent key assets for the position
- To supervise and ensure that the CRO and/or Providers selection for Clinical Studies is fit for purpose for the overall project development requirements
- Participates in the preparation of the documentation for eCTD submissions
- Provides strategic and operational input/support to the CPM during study design, Clinical Protocol Approval Committee preparation
- Contribute as CDP team member to the preparation of the update following committee:

- CPRF (Clinical Project Review Forum) update;
- PRM (Project Review Committee meeting)
- XRC or other according to Company need
- Involved in the writing/review of SOPs and working instructions (WI).
- Performs Line Management of Clinical Project Managers
- Project Management:

- Supervises the development of full synopsis and protocol according to Study Outline contained in the CDP and of any other important study-related documentation
- Ensures that the CPMs develop the timelines/GANTT chart on the clinical operations activities within an assigned study
- Supports the CPMs in the selection process for the CRO and/or other service providers
- Acts as escalating contact for CRO and/or other service provider.
- Prepares in collaboration with the Head of Clinical Project Management Unit the forecasting for future studies
- Supervise the study budget prepared by CPM to be validated during the CPAC. Shares the budget proposed with the with the Head of Clinical Project Management Unit
- Supervises variations of the study budgets compared to forecast & preclosing. Twice a year, reviews the forecast & preclosing budgets prepared by the CPMs

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