Clinical Project Manager

Date:  1 Jun 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 study progress. 
-    Study results and related deliverables: 

  • Prepares the Clinical Study Report (CSR) in cooperation with the Medical Writer, reviews the CSR/CIR, coordinates its review/approval by required members. Reviews the layman summaries and study summaries for authorities.
  • Supports and/or coordinates the presentation of clinical study results internally and externally as well as the preparation of manuscripts for the full paper publication.

Experience Required

At least 5 years of experience in a similar position in a pharmaceutical company or CRO.
Track record of achievements in successful planning and execution of at least 5 clinical studies.
Added value will be given for direct experience in implementation of centralized systems set up and large clinical trial experience in respiratory therapeutic area

Education

Degree in Life Sciences or equivalent.

Languages

English fluent

Technical Skills

Professional skills needed to hold the position

Soft Skills

  • Problem solving
  • Leadership and social influence
  • Quality orientation
  • Team working
  • Decision making

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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