IQVIA
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 home-based in Italy. 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 regional/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 regional/local level. CTMs contribute to delivery of sponsor´s pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites
• Provides leadership and direction to the Operational Unit trial team and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators
• Responsible for steering and directing clinical trial activities, including patient and site engagement activities and interaction with multiple internal and external stakeholders and trial team members at a regional/local and global level
• Responsible for managing the planning, implementation and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues
Trial Preparation, Conduct and Closeout:
• Accountable for the trial activities for responsible R/OPU
• Verify the trial is conducted in compliance with GCP-ICH, local/global regulations, application SOPs and according to the trial protocol by overseeing CRO and internal team activities
• Creation, management, and review of the R/OPU trial budget to verify appropriate level of financial oversight and planning accuracy
• Appropriate trial-specific training of R/OPU internal and external partners.
• Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; 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 & Background
• Master’s degree or higher in Life Sciences preferred
• Extensive experience in clinical research, including a minimum of 3 year in clinical trial management
• Mandatory prior involvement in clinical trials conducted in Italy
• Experience with Early Phase clinical trials (Phase I and Proof-of-Concept) is an advantage
Regulatory & Quality Expertise
• Expert knowledge of applicable clinical research regulations, including GCP and ICH guidelines
• Strong attention to detail, accuracy, and a results-oriented, quality-driven approach
Project, Financial & Vendor Management
• Strong understanding of project financials, including contractual obligations and financial implications
• Proven experience in vendor selection, oversight, and effective vendor management
• Ability to organize resources, plan activities in advance, and adapt to changing circumstances
Therapeutic Area knowledge
• Previous experience in Oncology
Leadership & Decision-Making
• Demonstrated leadership capability to deliver results through others, ensuring quality, timelines, and performance management, including feedback
• Ability to make sound decisions by synthesizing complex and disparate information
• Experience influencing business partners within matrix and cross-functional environments
Organizational & Problem-Solving Skills
• Excellent organizational, planning, time-management, and prioritization skills, with the ability to manage multiple projects and conflicting priorities
• Strong analytical and problem-solving skills, with a strategic, solution-oriented mindset
Communication & Collaboration
• Excellent written and verbal communication skills
• Fluency in Italian language (minimum C1 level) and very good command of English
• Strong collaboration and customer service skills
• Proven ability to work across geographies with cultural awareness and sensitivity
IT & Practical Requirements
• Very good computer and software skills, including Microsoft Word, Excel, and PowerPoint
• Location: Lombardy
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is 41 000,00 € - 79 800,00 €. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). 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.