Global Clinical Operations Lead - Strategy & Delivery (Remote)

Chiesi; L'Aquila; Ibrido; EUR 110.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Remote work options

Descrizione del lavoro

Chiesi is seeking an experienced Clinical Operations Lead to guide both strategic and hands-on management of global clinical development programs spanning Early Phase, Late Phase and RWE. You will mentor CPMs, oversee end-to-end operations, manage budgets and vendors, and drive risk and quality governance within a highly collaborative biopharma group with a patient-focused mindset.

The role requires advanced life sciences education and extensive CRO/pharma operations experience, with strong CDP

Competenze

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
• Significant experience in Clinical Operations in pharma/biotech or CRO.
• Proven experience managing global clinical development programs across Early Phase, Late Phase and RWE.
• Strong understanding of CDPs and clinical development processes.
• Experience coordinating cross-functional teams and acting as key interface between Clinical Operations and other functions.
• Solid knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience in CRO selection, oversight, and vendor management.
• Strong project/program management skills with timelines, milestones, risk management, and budget oversight.

Mansioni

• Lead program strategy and ensure study alignment within the program.
• Contribute to Clinical Development Plan feasibility, timelines, geographic strategy, and budget.
• Maintain integrated timelines and milestones including go/no-go decisions.
• Serve as primary Clinical Operations interface for cross-functional teams.
• Oversee end-to-end Clinical Operations activities.
• Support CPMs on operational decisions and compliance (ICH-GCP, SOPs).
• Contribute to study design and feasibility assessments (CPAC).
• Ensure consistency across studies within the program.
• Define and oversee vendor/CRO strategies.
• Support RFPs, evaluations, and Bid Defense Meetings.
• Manage escalations and vendor governance.
• Accountable for program-level budget with planning, forecasting, and variance analysis.
• Participate in governance bodies and present updates/risks.
• Provide functional supervision and escalation support to CPMs.
• Coach and develop CPMs (IDPs, objectives).
• Drive risk mitigation, CAPAs, and inspection readiness.
• Support regulatory documentation (eCTD, CSR/CIR) and registry submissions.
• Support SOPs and continuous improvement initiatives.
• Ensure compliance with required training.

Conoscenze

Program management

Clinical operations

Leadership

Budget oversight

Risk management

Vendor management

Cross-functional leadership

CDP planning

Project governance

Strategic thinking

Formazione

Advanced degree in Life Sciences

Descrizione del lavoro

Chiesi is seeking an experienced Clinical Operations Lead to guide both strategic and hands-on management of global clinical development programs spanning Early Phase, Late Phase and RWE. You will mentor CPMs, oversee end-to-end operations, manage budgets and vendors, and drive risk and quality governance within a highly collaborative biopharma group with a patient-focused mindset.

The role requires advanced life sciences education and extensive CRO/pharma operations experience, with strong CDP