Clinical Project Manager-Maternity Cover

On behalf of our Client, Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, IQVIA is looking for a Clinical Project Manager (fixed-term maternity cover) to join an exciting working environment in a dynamic and international atmosphere.

Purpose

The Clinical Project Manager will be accountable for the coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi’s goals and medical/scientific standards.

Main responsibilities

• Makes operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, and 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) and 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 assesses the proposals; reviews scope of works and overall budget.
  • Responsible for management of the Clinical CRO/Providers acting as the primary contact for the Clinical (CRO) but also for 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 and 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 a monthly basis. Twice a year provides forecast & pre‑closing 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 and 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.

Requirements

• Degree in Life Sciences or equivalent
• At least 2–3 years of experience in Project Management or as a Clinical Research Associate (CRA)
• 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
• Planning & Organizing
• Problem Solving
• Results Driven
• Priority Setting
• Fluent English

Type of contract

• National Collective Labour Agreement: Chemical and Pharmaceutical Industry
• Contract Type: Fixed Term-temporary position covering maternity leave
• Salary Range or Gross Annual Salary: Minimum salary foreseen for the role starting from €54,160 gross per year.

The role also includes

• a variable bonus/MBO ranging between 8% and 10%
• private health insurance (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector)
• pension fund (please note that this is not the one provided under the National Collective Labour Agreement for the Chemical-Pharmaceutical sector)
• flexible benefits/corporate welfare.

The salary range is defined based on experience, skills, and internal equity criteria.

Career progression and compensation review are based on transparent, objective criteria.

We are committed to fair and equal pay practices, in line with applicable pay transparency regulations (EU Directive 2023/970).

Candidates of both sexes are eligible in compliance with L.903/77.