Senior Clinical Study Manager — Global Ops & CRO Leadership

Recordati; Lombardia; Hybrid; EUR 51,000 - 63,000; Full time

Job summary

Recordati in Italy seeks a Clinical Study Manager responsible for the end-to-end operational delivery of assigned clinical studies, ensuring quality, timelines, budget and compliance. You will lead cross-functional study teams and oversee CROs, vendors and site-facing activities.

You will manage risk, governance and escalation while driving study startup, activation, recruitment, data management plans, CSR completion and TMF quality across global trials.

Qualifications

• Minimum 6–8 years of clinical research experience in a pharmaceutical, biotechnology or CRO environment.
• At least 3–4 years of direct clinical study management experience.
• Demonstrated involvement in cross‑functional, multicultural and international clinical trials.
• Proven ability to manage study delivery across quality, compliance, budget and timelines.
• Proven experience in CRO and vendor oversight, including performance management and issue escalation.

Responsibilities

• Lead the operational delivery and cross-functional coordination of assigned clinical studies across the study lifecycle, from protocol development through completion of the final Clinical Study Report (CSR).
• Contribute to the development of relevant sections of the clinical trial protocol and associated study documents, including the informed consent form (ICF).
• Lead operational feasibility, country and site-selection strategy, study start-up planning, site activation and recruitment performance management, in collaboration with relevant internal functions and external partners.
• Develop and drive risk-management strategies to proactively identify, mitigate and resolve operational bottlenecks.
• Manage external partners, CROs and vendors and maintain documented sponsor oversight of delegated activities, including performance against contractual obligations, timelines, quality standards and KPIs, as well as risks, corrective actions and escalation.

Skills

Clinical study management

Cross-functional leadership

Budget oversight

Vendor governance

Independent working

GCP knowledge

English proficiency

Education

Bachelor’s degree in Life Sciences, Clinical Research, or a related field

Tools

eCRF/EDC

IRT/IXRS

CTMS

eTMF platforms

Job description

Recordati in Italy seeks a Clinical Study Manager responsible for the end-to-end operational delivery of assigned clinical studies, ensuring quality, timelines, budget and compliance. You will lead cross-functional study teams and oversee CROs, vendors and site-facing activities.

You will manage risk, governance and escalation while driving study startup, activation, recruitment, data management plans, CSR completion and TMF quality across global trials.