Clinical Project Manager

2 settimane fa


Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**: 3 May 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
- 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 for communication to all stakeholders on the progress of the study
- Accountable to maintain and respect budget according to study signed contract

Main Responsibilities
- Makes operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, secures compliance with ICH and Chiesi Standard Operating Procedures (SOPs) or any local regulations.
- Can be involved in the writing/review of SOPs and working instructions (WI). Completes assigned SOPs/WIs/processes trainings according to company process.
- Project Management:
Develops full synopsis and protocol, and related documents based on the Study Outline contained in the Clinical Development Plan (CDP) involving all relevant contributors persons.
Collaborates with relevant contributors and accountable team members to ensure timely production and review of other important study-related.
**Contributes to the CRO and/or Providers selection**: responsible for the implementation of the Request For Proposal (RFP); reviews and assess the proposals; reviews scope of works and overall budget.
Responsible for management of the Clinical CRO/Providers Acting as primary contact for Clinical (CRO) but also internal customers. Ensures adherence to scope of work within timelines and budget. Performs co-monitoring when needed, as specified in SOP and collaborates with Site Engagement Managers for study site performance and relationship consolidation.
Collaborates in the set-up and maintenance of the Study Risk Register. Responsible for ongoing clinical risk review during study conduct involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors).
**Prepares and coordinates/collaborates to scientific meetings**: investigators’ meeting, scientific/safety board meetings, Data reviews and any other study-relevant meeting(s).
**Ensures registration of the study in public registries (e.g**: clinicaltrial.gov, European registry, etc ).
- Clinical Trial Supplies: liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan Reviews the labels and leaflets.
- Responsible for the management of the study eTMF (related to clinical operations) and all its related activities (such as QC and health checks) with the Clinical Trial Administrator (CTA) as per Chiesi SOP. Accountable for the overall completeness of the whole study eTMF and for ensuring that the study eTMF is archived as per Chiesi SOP.
- Study Budget: accountable for budget management and reconciliation as well as control of invoices on monthly basis. Twice a year provides forecast & preclosing budgets according to


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