Clinical Study Manager

Job Purpose

We are looking for a Clinical Study Manager who is accountable for the end-to-end operational delivery of assigned clinical studies, ensuring that quality, timelines, budget, compliance and performance expectations are met. 
The role provides senior operational leadership to cross-functional study teams and oversees CROs, vendors and site-facing activities. 
The Clinical Study Manager anticipates risks, drives timely decisions and issue resolution, and ensures clear escalation and governance throughout the study lifecycle.

Key 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.
•    Chair cross-functional Clinical Trial Team (CTT) meetings and align Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Medical Monitoring and other relevant functions.
•    Serve as the primary operational point of contact for assigned studies and ensure appropriate governance, communication, decision-making and escalation.
•    Ensure cross-functional alignment and timely delivery of study-specific documentation, including case report forms, data management plans, monitoring plans, monitoring oversight plans, project-specific training plans, data review plans and statistical analysis plans, while preserving the accountability of each relevant function for its specialist documents.
•    Oversee study-level data review and data-cleaning activities in collaboration with Data Management, Medical and other relevant functions, ensuring timely resolution of data-related issues.
•    Maintain study inspection readiness and oversee the completeness, quality and timeliness of the Trial Master File (TMF), ensuring that identified gaps are addressed and appropriately escalated.
•    Collaborate with Clinical Trial Supply to ensure investigational product availability and accurate forecasting.
•    Manage and track the study lifecycle budget, including forecasts, accruals, change orders, invoice review and explanation of variances, in coordination with Project Management and Finance as applicable.
•    Review and approve vendor invoices in line with the internal processes.
•    Oversee or support clinical trial registration and results disclosure in ClinicalTrials.gov and other applicable public registries, in accordance with regulatory requirements and internal procedures.
•    Lead operational study close-out, including site and vendor close-out, final reconciliation, TMF closure, lessons learned and operational input into the CSR.
•    Contribute to the development and continuous improvement of relevant SOPs, working instructions, templates and Clinical Operations processes in collaboration with Quality Assurance and other relevant functions.

Required Education

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

Required Skills and Experience

•    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.
•    Ability to work independently while effectively leading and contributing to cross-functional teams.
•    Rare disease experience is preferred.

Technical Competencies

•    Excellent knowledge of Good Clinical Practice, clinical trial design and the operational delivery of global clinical studies.
•    Proficiency with clinical trial systems, including eCRF/EDC, IRT/IXRS, CTMS and eTMF platforms.
•    Strong operational planning, budget oversight, risk management, vendor governance and study performance-management capabilities.
•    Ability to interpret study metrics, identify trends and translate operational data into decisions and corrective actions.

Required Behaviours and Competencies

•    Senior operational leadership and accountability, with a strong focus on delivery and quality.
•    Clear, concise and influential communication with internal and external stakeholders.
•    Strong organisation, prioritisation and tracking skills, with demonstrated ability to meet timelines.
•    Proactive problem-solving, sound judgement and timely escalation of risks and issues.
•    Collaborative mindset and ability to build effective relationships in complex matrix environments.
•    Adaptability, resilience and ability to lead through changing priorities.
•    Commitment to patient safety, data integrity, compliance and continuous improvement.

Required Languages

English: full professional proficiency, written and spoken, is required. 
Additional languages are considered an advantage.

Salary

Gross Annual Salary starting from: 57.000€
Please note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts. Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity. At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of your total rewards package will be shared and discussed with you during the recruiting process.