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Clinical Trial Manager

2 ore fa

Roma, Lazio, Italia IQVIA A tempo pieno

Rome, Italy | Full time | Hybrid | R1508350

The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with clinical research projects in different therapeutic areas.

Clinical Trial Managers are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. Clinical Trial Manager is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.

Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. The Clinical Project Manager's focus is on leveraging therapeutic expertise and IQVIA's suite of solutions to drive operational excellence and strategic leadership with our customers.

Main Responsibilities

  • Responsible for delivery and management of smaller, less complex, local studies.
  • Develop integrated study management plans with the core project team.
  • Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
  • Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
  • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
  • Monitor progress against contract and prepare/present project information proactively to stakeholders internally and externally.
  • Manage risk and contingencies proactively and lead problem solving and resolution efforts.
  • Achieve project quality by identifying quality risks and issues.
  • May serve as primary or backup project contact with customer and would then own the relationship with the project's key customer contacts, as well as communicate with IQVIA business development representatives, as necessary.
  • Ensure the financial success of the project.
  • Forecast and identify opportunities to accelerate activities to bring revenue forward.
  • Identify changes in scope and manage change control process as necessary.

Required Skills and Qualifications

  • Bachelor's Degree Life sciences

  • Minimum 1 year of proven clinical trial management experience.

  • At least 3 years of prior work experience as a Clinical Research Associate.
  • Therapeutic area knowledge in Oncology.
  • Knowledge of job area, typically obtained through advanced education combined with experience.
  • Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
  • Fluent language skills in English and good knowledge of Italian at preferably least C1 level.
  • Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines and relevant local laws.
  • Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint.
  • Effective communication, organizational and problem-solving skills.
  • Strong leadership competencies and ability to establish and maintain effective working relationship
  • Willingness to work hybrid in Rome with regular visits in the office location (3 times a week).

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