Senior Clinical Project Manager

Chiesi Group; Parma; Ibrido; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Ticket restaurant

Relocation support

Remote work options

Descrizione del lavoro

Chiesi Group in Parma, Italy, is seeking an experienced Clinical Operations Lead to coordinate the operational management of clinical studies, oversee CROs, and ensure quality standards across trials.

You will manage 1–3 studies, liaise with vendors and internal teams, and drive on-time delivery within budget. A Life Sciences degree and 3+ years’ pharma experience are required; a base salary starts at €52,000 with a comprehensive benefits package and relocation support.

Competenze

• At least 3 years of experience in a similar position in a pharmaceutical company.
• Track record of achievements in planning and execution of at least 5 clinical studies.
• Degree in Life Sciences or equivalent.
• Knowledge of principles of clinical study design.
• Knowledge of principles of Clinical Research Statistics.
• Knowledge of planning tools and planning principles.
• Knowledge of ICH/GCP and company SOPs.
• Familiar and up to date with relevant literature.

Mansioni

• Coordinate operational management of assigned projects to develop compounds in line with Chiesi goals and medical/scientific standards.
• Communicate progress of the study to all stakeholders.
• Maintain and respect budget according to the study signed contract.
• Typically manages 1-3 clinical trials, depending on size, complexity, phase of development and therapeutic area.
• Manage the Clinical CRO/Providers.
• Act as primary contact for Clinical (CRO) but also internal customers; represent the Study Team for operational parts of the trials.
• Ensure adherence to scope of work within timelines and budget.
• Review study related documents prepared by CRO and perform co-monitoring when needed.
• Collaborate in setup and maintenance of the Study Risk Register and clinical risk reviews.
• Manage the study eTMF with the Clinical Trial Administrator.
• Prepare and coordinate scientific meetings and expert/KOL contracts.
• Coordinate CTS strategy with CTS and manage CTS deliveries.
• Prepare CSR in cooperation with Medical Writer and coordinate presentations.

Conoscenze

Clinical study management

Budget management

Stakeholder communication

Team coordination

ICH/GCP knowledge

Planning tools

Formazione

Life Sciences degree or equivalent

Strumenti

Planning tools

Descrizione del lavoro

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.
• Reviews study 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. Responsible clinical 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 Sciences (biological science, pharmacy or other health related discipline) or equivalent.
• Knowledge of principles of clinical study design
• Knowledge of principles of Clinical Research Statistics
• Knowledge of planning tools and planning principles
• Knowledge of ICH/GCP and company SOPs
• Knowledge of GLP for bio analytical assays (for Clinical pharmacology studies)
• Familiar and up to date with relevant literature

Location

The position is based at our headquarters in Parma and offers flexible working arrangements, including both hybrid and predominantly remote options.

Compensation range

The minimum salary for this role is €52.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, ticket restaurant and more.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi 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.