Clinical Project Manager - Temporary

Chiesi Research & Development is seeking a Clinical Trials Manager to coordinate the operational management of assigned projects, ensuring development of compounds in line with Chiesi’s goals and medical/scientific standards.ResponsibilitiesAccountable for coordination of the operational management of assigned projects to meet scientific and medical standards.Communicate progress of the study to all stakeholders.Maintain and respect the budget according to the signed contract.Manage 1‑3 clinical trials, depending on size, complexity, phase and therapeutic area.Manage Clinical CRO/Providers and act as primary contact for the CRO and internal customers.Represent the Study Team for the operational part of the clinical trials allocated to you.Ensure adherence to scope of work within timelines and budget.Review study‑related documents prepared by the CRO (project plan, monitoring plan, risk management plan, site contracts when required) and perform co‑monitoring when specified in SOP.Collaborate in setting up and maintaining the Study Risk Register;

conduct clinical risk reviews with all relevant study functions and follow up on actions with vendors (CRO, direct and third‑party vendors).Manage the study eTMF (clinical operations) with the Clinical Trial Administrator (CTA).Prepare and coordinate scientific meetings: investigators’ meetings, scientific/safety board meetings, data reviews and other relevant meetings.Manage the preparation of experts/KOL contracts when an expert is dedicated to the study.Prepare and review the Clinical Study Report (CSR) in cooperation with the Medical Writer, and obtain approval.Support and/or coordinate the presentation of clinical study results internally and externally.Liaise with the Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan and manage the CTS once delivered to sites.Ensure compliance with SOPs and all necessary quality standards;

lead corrective and preventive actions and follow‑ups (e.G., in case of audits).Provide clinical operations input during study design, Clinical Protocol Approval Committee (CPAC) and Extended Clinical Team Meetings.Manage budget preparation and ongoing study budgets in collaboration with the Clin Ops Lead.QualificationsAt 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 Sciences (biological science, pharmacy or other health‑related discipline) or equivalent.Knowledge of principles of clinical study design, clinical research statistics and planning tools.Knowledge of ICH/GCP and company SOPs.Knowledge of GLP for bio‑analytical assays (for clinical pharmacology studies).Familiarity with and up‑to‑date knowledge of relevant literature.LocationThe position is based at our headquarters in Parma, Italy, and offers flexible working arrangements including hybrid and predominantly remote options.CompensationMinimum salary €46,000, aligned to our salary framework, with final offer reflecting skills, experience and internal equity.Eligible for an annual bonus scheme, subject to company and individual performance.BenefitsComprehensive benefits package including company car, pension, private medical insurance, wellbeing and flexible benefits programmes.Robust relocation support, tax assistance for foreign colleagues, and flexible working arrangements.Equal Employment OpportunityChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.#J-18808-Ljbffr