Clinical Study Manager
IQVIA LLC ·
ppThe IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. /ppJoining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients. /ppWe currently offer the exciting opportunity to join the team as Clinical Study Manager in full-time and work home-based in Italy. /ph3MAIN RESPONSIBILITIES /h3ulliPlans and leads execution of day-to-day activities for the monitoring of a complex clinical study and communicates consistently with the clinical team providing project objectives, expectations, and status updates. /liliHas the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. /liliProvides Project Oversight Leadership for Clinical Deliverables. /liliLeads and manages the clinical teams. /liliLeads and supports the relevant staff (ie. local start-up staff, local and global regulatory affairs staff, inhouse clinical staff, etc) to drive successful activation of trial sites. /liliMonitors the quality of clinical activities and addresses quality issues with the appropriate team member. /liliReviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up, and resolution of site issues. /liliWorks with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks. /liliCreates and maintains project-specific plans, documents, and tools for the clinical team. /liliSupports the CRAs with site monitoring activities and provides suggestions and solutions to site issues. /liliOversees the relevant regulatory and in-house clinical staff to ensure that all non-safety periodic updates, progress reports, and renewals, and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial. /liliActs as coordinating manager to ensure consistency of training, processes, and systems-related activities as well as ad-hoc coordinating activities. /li /ulh3REQUIRED SKILLS AND QUALIFICATIONS /h3ulliBachelor degree in related discipline, preferably in life science. /liliFive or more years of experience in clinical research, including a minimum of 4 years project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job. /liliGood knowledge of international guidelines ICH GCP as well as relevant local regulations. /liliProven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality. /liliPrevious work experience in TA's: Oncology or Onco-hematology is required. /liliGood knowledge of the Drug Development Process. /liliExcellent knowledge of spoken and written English and Italian language. /liliGood ability to learn and to adapt to work with IT systems. /liliEffective decision-making is crucial for resolving challenges and ensuring alignment with overall study goals. /liliExperience in monitoring study activities for compliance and inspection readiness. /liliStrong interpersonal skills are vital for collaborating with internal teams, stakeholders, and external vendors. /liliA deep understanding of clinical operations processes, including trial data collection and management, is paramount to ensuring successful study execution. /liliLocation in Milan and Rome is preferred. /li /ulpLocation in Milan and Rome is preferred.
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. /ppIQVIA 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 /ppIQVIA 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. /ppThe potential base pay range for this role, when annualized, is 53 200,00 € - 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. /ppIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.
No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. /ppThank you for your interest in growing your career with us. /p /p