Clinical Trial Manager

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Clinical Trial Manager (CTM) – based in Rome is accountable for end-to-end study operational oversight and delivery at country level (Italy, Greece, Israel and Croatia), ensuring adherence to timelines, budget and quality standards. Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.

Key Responsibilities

Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams.
Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
Plans, develops and executes timelines and activities for start‑up in collaboration with the local study team and other relevant stakeholders.
Implements country and site level patient recruitment strategy and risk mitigation, coordinating and ensuring country level study enrolment targets and timelines are met.
Leads problem‑solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder(s).
Assesses and sets up vendors during study start‑up period (locally).
Participates in Investigator Meetings and prepares related materials.
Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and that access to eDC and vendor systems is available for the country and clinical trial site personnel, including uploading documents in eTMF.
Validates study‑related materials (i.e. protocol, ICF, patient material).
Reviews country and site‑specific documents (e.g. ICF, patient material) and prepares site‑level ICF and other documents where applicable.
Supports preparation of materials for Site Initiation Visits.
Verifies and confirms with local team eTMF completeness (Country and Site level). Prepares investigator sites to conduct clinical trials by verifying acceptability of Clinical Trial Package (CTP) documentation.
Acknowledges Site Monitoring visit reports, takes action within specified timelines and escalates issues, ensuring appropriate documentation.
Coordinates database locks and query follow‑up, ensuring timelines are met.
Ensures inspection readiness of assigned trials within country and provides support to Health Authority inspection and pre‑inspection activities.
Coordinates and completes Corrective Actions / Preventive Actions (CAPA), ensuring implementation for Country audit level findings and drives CAPA review, implementation and completion.
Coordinates study team meetings locally.
Supports stakeholder resolution of queries related to site invoices and coordinates patient compensation claims (if applicable).
Collaborates with the local study team to support management of site relationships (may include CRO related issues).
May support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs); may perform site closure activities, including post‑close‑out; may act as point of contact for Sites.
As required per country requirements, performs or supports preparation of submissions to Health Authorities, including follow‑up until approval, covering…