Clinical Study Manager

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life. Job Purpose

The Clinical Study Manager (CSM) provides end to end operational leadership for assigned clinical trials, ensuring delivery on time, within budget, and to the highest quality standards, while maintaining continuous inspection readiness. As a core member of the global, cross functional Clinical Trial Team (CTT), the CSM plays a key role in driving quality focused, risk based trial execution, coordinating internal functions and external partners to ensure compliant delivery in line with ICH GCP, applicable regulations, and Recordati SOPs. This role requires demonstrated experience managing complex interventional and non-interventional clinical trials and a strong capability to apply Risk Based Quality Management (RBQM) principles to proactively identify risks, interpret signals, and implement effective mitigation strategies throughout the trial lifecycle. Key Responsibilities

Clinical Trial Delivery & Operational Leadership

Lead the operational planning and execution of complex interventional clinical trials from study start up through close out, applying RBQM principles throughout Ensure study execution is aligned with the global study strategy, timelines, and key milestones defined by the Lead Clinical Study Manager Act as a fully accountable member of the Clinical Trial Team, contributing to operational decisions, issue escalation, and resolution Quality, RBQM & Inspection Readiness

Drive proactive, risk based oversight of trial conduct, identifying emerging risks, trends, and quality signals and ensuring timely mitigation actions Champion a quality by design mindset, with strong focus on patient safety, data integrity, and regulatory compliance Ensure Trial Master File (TMF) completeness and inspection readiness throughout the study lifecycle Contribute to audit and inspection preparedness and support follow up activities as required Vendor & Stakeholder Oversight

Act as primary point of contact for CROs and external vendors, ensuring delivery against quality expectations, timelines, scope, and contractual obligations Monitor vendor performance using data driven KPIs, quality metrics, and RBQM outputs Coordinate study activities across Data Management, Biostatistics, Drug Supply, Pharmacovigilance, Regulatory Affairs, and other key stakeholders Study Documentation & Data Activities

Contribute to the preparation and review of key clinical documents (e.g. protocol sections, ICFs, CSRs) in collaboration with global functions Actively participate in data review and data cleaning activities, supporting timely, high quality database lock Support preparation of regulatory documents (e.g. IB, ASRs) and results posting in public databases (e.g. ClinicalTrials.gov, EudraCT) Governance, Reporting & Budget

Provide clear, structured reporting on study progress, risks, issues, and mitigation plans to the Lead Clinical Study Manager and Clinical Trial Team Actively participate in and, when appropriate, facilitate Clinical Trial Team meetings, supporting effective governance and decision making Support trial level budget development, tracking, and forecasting in collaboration with relevant line functions Required Education

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific discipline. Required Skills And Experience

4–6 years of clinical trial experience within pharma, biotech, or CRO environments Hands on experience managing complex global interventional clinical trials is mandatory Experience gained through a combination of site level roles (e.g. CRA) and clinical study management responsibilities Demonstrated experience overseeing CROs and external vendors, with accountability for quality and performance Strong experience across study start up, recruitment oversight, and close out Sound knowledge of regulatory and operational requirements, including inspection readiness Ability to manage multiple priorities in a complex, matrix, cross functional environment Technical Competencies

In depth knowledge of ICH GCP and EU Clinical Trial Regulation Strong understanding of clinical trial operational processes across the full lifecycle Experience with clinical trial systems (eTMF, CTMS, EDC, safety databases) Practical application of Risk Based Quality Management (RBQM) principles Ability to interpret global protocols and translate them into effective operational execution Required Behaviours And Competencies

Proactive, solution oriented mindset with strong risk anticipation and mitigation capability Excellent stakeholder management and communication skills High level of ownership and accountability for trial delivery and quality outcomes Collaborative and effective in cross functional, international teams Resilient and adaptable in a fast moving clinical development environment Strong personal commitment to quality, compliance, and patient safety Required Languages

Fluent English (spoken and written) – mandatory Additional languages – preferred At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

#J-18808-Ljbffr