Senior Clinical Program Lead - Trials & Strategy (Remote)

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 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.