Clinical Trial Manager - Single Sponsor Dedicated
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client's project team in the execution of clinical trials.
Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
We currently offer the exciting opportunity to join the team as Clinical Trial Manager in full-time and work hybrid in Italy (Lombardy).
In this role you will be accountable for the operational and scientific oversight, the set-up, execution and delivery of your assigned clinical trials at the local level .
working closely together with the Clinical Trial Lead, the CRAs and the regulatory start-up team in the assigned trial.
KEY RESPONSIBILITIES Accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the local level .
CTMs contribute to delivery of sponsor ?s pipeline through accurate planning and efficient execution of trials that bring speed and oversight of trial preparation to verify trial team members are aligned and on track Verifies and provides input into the country and site level feasibility and OPU commitment Development and implementation of country level engagement plans,
recruitment planning and risk mitigation Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance Verify timely responses to questions from Regulatory Authority/Ethic Committee and other external stakeholders Maintains oversights during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; verifies budget oversight, including support of regular clinical quality monitoring, and safety reporting Support CTL during investigator meetings Responsible for timely, complete, and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors Verifies timely submission of the CTR to Regulatory authority/Ethics Committee and other external stakeholders as required by local regulations Shares information on trial results with Investigational sites and, if applicable, patients Leadership competencies Create an environment that inspires, motivates, and empowers colleagues, contributing to acceleration of clinical development timelines and value creation for patients Embraces innovative approaches and technologies, as well as creates and maintains a culture that drives empowerment and smart risk taking REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE Education location; and/or schedule (full or tempo parziale).
Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
We currently offer the exciting opportunity to join the team as Clinical Trial Manager in full-time and work hybrid in Italy (Lombardy).
In this role you will be accountable for the operational and scientific oversight, the set-up, execution and delivery of your assigned clinical trials at the local level .
working closely together with the Clinical Trial Lead, the CRAs and the regulatory start-up team in the assigned trial.
KEY RESPONSIBILITIES Accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the local level .
CTMs contribute to delivery of sponsor ?s pipeline through accurate planning and efficient execution of trials that bring speed and oversight of trial preparation to verify trial team members are aligned and on track Verifies and provides input into the country and site level feasibility and OPU commitment Development and implementation of country level engagement plans,
recruitment planning and risk mitigation Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance Verify timely responses to questions from Regulatory Authority/Ethic Committee and other external stakeholders Maintains oversights during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; verifies budget oversight, including support of regular clinical quality monitoring, and safety reporting Support CTL during investigator meetings Responsible for timely, complete, and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors Verifies timely submission of the CTR to Regulatory authority/Ethics Committee and other external stakeholders as required by local regulations Shares information on trial results with Investigational sites and, if applicable, patients Leadership competencies Create an environment that inspires, motivates, and empowers colleagues, contributing to acceleration of clinical development timelines and value creation for patients Embraces innovative approaches and technologies, as well as creates and maintains a culture that drives empowerment and smart risk taking REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE Education location; and/or schedule (full or tempo parziale).
Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.