Senior Clinical Project Manager

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Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Italy, IT

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

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, global technical development, 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), Toronto (Canada) and Shanghai (China).

Who we are looking for

This is what you will do

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

You will be responsible for

Typically manages 1-3 clinical trials, depending on size, complexity, phase of development and therapeutic area.

Responsible for management of the Clinical CRO/Providers

Acting as primary contact for Clinical (CRO) but also internal customers;

representing the Study Team for operational part of the clinical trials allocated to her/him.

Ensures adherence to scope of work within timelines and budget.

Reviewsstudy related documents prepared by CRO (project plan, monitoring plan, risk management plan, site contracts when required,…). Performs co-monitoring when needed, as specified in SOP.

Collaborates in the set-up and maintenance of the Study Risk Register. Responsibleclinical risk review involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors).

Responsible for the management of the study eTMF (related to clinical operations)with the Clinical Trial Administrator (CTA).

Prepares and coordinates/collaborates to scientific meetings: investigators' meeting, scientific/safety board meetings, Data reviews and any other relevant meeting(s).

Manages the preparation of experts/KOLs contract if any (when expert is dedicated to the study).

Study results and related deliverables:
-Prepares & reviews he Clinical Study Report (CSR) in cooperation with the Medical Writer, and its approval.
-Supports and/or coordinates the presentation of clinical study results internally and externally

Clinical Trial Supplies:

liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan

Manages the CTS once delivered to sites

Ensures that the trial complies to SOPs and all necessary quality standards. Responsible for corrective and preventive actions and follow-ups (e.g. in case of audits).

Provides clinical operations input during study design, Clinical Protocol Approval Committee (CPAC), Extended Clinical Team Meetings

Budget Management

prepares and presents budget in collaboration with Clin Ops Lead

accountable for budget management for the ongoing studies

You will need to have

At least 3 years of experience in a similar position in a pharmaceutical company.

Track record of achievements in successful planning and execution of at least 5 clinical studies.

Degree in Life Scie