SENIOR CLINICAL PROJECT MANAGER

at ClinChoice (View all jobs)
Italy
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice, is searching for an experienced Senior Project Manager to work with one of our pharmaceutical partners. This can be a home-based position, with occasional visits to the office. It will initially be a Fixed Term Contract until the end of December 2025.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

EDUCATION, EXPERIENCE AND SKILLS:

• University Degree in scientific, pharmacy or other health related discipline, or equivalent.
• Proven experience as Clinical Project Manager.
• Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Knowledge of planning tools and planning principles.
• Knowledge of clinical research process from Phase I/II through final regulatory submission.
• Prior experience in electronic data capture preferred.
• Fluent in English and Italian.
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).Willingness to travel.

• Supervising the assigned clinical research projects.
• Coordinating and maintaining the planning of the activities for the assigned projects.
• Management of the CRO by acting as primary contact, managing day-to-day relationships, raising issues as soon as they are identified.
• Management of study budget, scope changes and financial reconciliation.
• Preparation and coordination of scientific meetings incl. KOLs meeting, Investigators’ meeting, blinded review meeting.
• Preparation, review and approval of Clinical Study Report (CSR) in cooperation with the Medical Writer and other required key team stakeholders.
• Reporting to Company’s senior management.
• Operational management coordination of assigned projects.
• Clinical Development Plan (CDP) definition in relation to studies’ operational aspects.
• Interactions with all functions supporting the Clinical Development Plan.
• Line Management of Clinical Project Managers (CPMs).
• Supervises Clinical Research Associates (CRAs) activities, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.
• Supervises the CTAs in archiving activities.Collaborates in complying and enforcing Company procedures.