Senior Clinical Study Lead, Global Trials

Recordati; Lombardia; In loco; EUR 51.000 - 63.000; Tempo pieno

Descrizione del lavoro

Recordati is seeking a Clinical Study Manager to oversee the end-to-end operational delivery of assigned clinical studies, ensuring quality, timelines, budget and compliance. You will provide senior leadership to cross-functional teams and govern CROs, vendors and site activities throughout the study lifecycle.

The role requires strong GCP knowledge, experience in global trials, and the ability to drive risk management and decision making in a complex matrix environment.

Competenze

• Bachelor’s degree in Life Sciences, Clinical Research, or a related field.
• 6–8 years of clinical research experience in pharma, biotech or CRO.
• 3–4 years direct clinical study management experience.
• Experience in cross-functional, multicultural, international trials.
• Proven ability to manage study delivery across quality, compliance, budget and timelines.
• CRO/vendor oversight experience including performance management.
• Strong leadership in cross-functional teams and excellent communication.
• Knowledge of GCP, trial design and global operational delivery.

Mansioni

• Lead operational delivery and cross-functional coordination across the study lifecycle.
• Contribute to protocol and study documents including ICF.
• Lead feasibility, site selection, start-up, site activation and recruitment management.
• Develop risk-management strategies to mitigate bottlenecks.
• Oversee CROs, vendors and sponsor oversight of activities and KPIs.
• Chair Clinical Trial Team meetings across Clinical Operations, Data Management and more.
• Be primary operational contact for assigned studies with governance and escalation.
• Ensure timely documentation delivery and data review plans with stakeholders.
• Oversee TMF quality, gaps and inspection readiness.
• Coordinate with Clinical Trial Supply for product availability and forecasting.
• Manage study lifecycle budget with PM and Finance, including invoicing variances.
• Review vendor invoices and support clinical trial registration and results disclosure.
• Lead study close-out and lessons learned for CSR input.

Conoscenze

Cross-functional leadership

Budget oversight

GCP knowledge

Vendor governance

Independent leadership

Communication skills

Global clinical studies

Clinical trial regulations

eCRF/EDC proficiency

Formazione

Bachelor’s degree in Life Sciences

Strumenti

eCRF/EDC

CTMS

eTMF

IRT/IXRS

Clinical data systems

Descrizione del lavoro

Recordati is seeking a Clinical Study Manager to oversee the end-to-end operational delivery of assigned clinical studies, ensuring quality, timelines, budget and compliance. You will provide senior leadership to cross-functional teams and govern CROs, vendors and site activities throughout the study lifecycle.

The role requires strong GCP knowledge, experience in global trials, and the ability to drive risk management and decision making in a complex matrix environment.