Clinical Research Manager

Proclinical is seeking a Clinical Research Manager to be based in Rome on a permanent basis. This role is primarily accountable for the end to end performance for assigned protocols in Italy in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Responsibilities:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
• Responsible for creating and executing a local risk management plan for assigned studies
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies
• Escalates as needed different challenges and issues
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
• Collaborates internally with HQ functions and locally with internal stakeholders to align on key decisions in his/her studies.
• As a customer-facing role, this position will build business relationships and represent company with investigators
• Shares protocol-specific information and best practices across countries\clusters

Skills and Requirements:

• 4-year degree (project management certification would be a plus)
• Oncology experience
• CRA background
• Local project management experience (this person will not get involved in global project management so if this is something they are looking for, then they will not be suitable)
• Must have experience in dealing with difficult sites
• Will not have Line Management responsibilities, only study management responsibilities

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Pontus Larsson on +44 203 3193 030 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.