Clinical Trial Manager

2 settimane fa

Milano, Lombardia, Italia IQVIA A tempo pieno
Job Title: Clinical Trial Manager

Job Summary:

We are seeking a highly skilled Clinical Trial Manager to join our team at IQVIA. As a Clinical Trial Manager, you will be responsible for leading the Study Management Team and ensuring the successful execution of clinical trials from start-up to close-out.

Key Responsibilities:

  • Lead the Study Management Team and ensure the timely completion of trial deliverables
  • Develop and implement trial management plans, including country and site feasibility, trial set-up, and trial execution
  • Collaborate with cross-functional teams, including data management, clinical supplies, and regulatory affairs
  • Ensure compliance with ICH-GCP, local laws and regulations, and company Standard Operating Procedures
  • Manage vendor relationships and ensure timely and accurate documentation and communication of trial progress
  • Act as primary contact for Country and Regional staff and local teams within GCDO
  • Partner with the Global Trial Lead to execute and oversee central activities from planning to close-out
  • Ensure issue escalation and drive issue resolution
  • Contribute to data collection to support the site selection process and participate in feasibility
  • Establish enrollment commitments and ensure actual enrollment meets projected commitments
  • Ensure the availability of robust recruitment/contingency plans are in place for each region
  • Perform Annual Quality Review of files and ensure archiving and retention of documents per set requirements
  • Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses
  • Oversight of selected vendors and status of related deliverables
  • Review and approve assigned vendor invoices/spend
  • Monitor budgets and expenditures as expected per planned trial budget
  • Create and update trial-specific documents, including Monitoring Guidelines, Informed Consent Form, and Investigational Medicinal product (IMP) related documentation
  • Provide input into cross-functional documents, such as safety-related documents, protocol deviations, and issue escalation processes
  • Provide central documents required for HA/EC/IRB submission
  • Ensure creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed
  • Responsible for the set-up, coordination, attendance participation of Investigator Meetings
  • Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader, and clinical supplies unit
  • Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge
  • Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes
  • Participate in preparation for, and conduct of, Health Authority inspections and internal audits
  • Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools
  • Coordinate data cleaning with some supervision towards a timely and successful database lock
  • Act as central expert for assigned protocol(s)
  • Sufficient therapeutic knowledge to support defined CTM roles and responsibilities
  • Contribute to process improvement and training, as applicable

Requirements:

  • BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
  • 6-8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience
  • Strong working knowledge of ICH-GCP, local laws and regulations
  • Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure
  • Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills
  • Effective leadership skills and ability to manage multiple stakeholders
  • Proven ability to lead a team through formation stages, up to operating as a high-performing team
  • Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness
  • Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years
  • Proven experience in proactive planning, risk mitigating, and gaining team consensus on updated plans during the project lifecycle
  • Strong project planning/management
  • Independent complex decision making
  • Solution-oriented and proactive risk identification and mitigation
  • Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems
  • Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring
  • Travel
  • Proficient in speaking and writing local country language and English
  • Effective verbal and written communication skills leading to successful team collaboration
  • Strong decision making. Solution-oriented
  • Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available
  • Experience in developing presentations and presenting key information to stakeholders
  • Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers

About IQVIA:

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://www.iqvia.com/

  • Clinical Trial Manager

    2 settimane fa

    Milano, Lombardia, Italia Bancroft School A tempo pieno

    Job Title: Clinical Trial ManagerWe are seeking a highly skilled Clinical Trial Manager to join our team in Italy, particularly in our Milan office. As a Clinical Trial Manager, you will be responsible for managing and providing accountability for day-to-day operations of clinical trials, ensuring compliance with ICH/GCP and all other applicable laws, rules,...

  • Clinical Trial Manager

    4 settimane fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About the RoleWe are seeking a highly skilled Clinical Trial Manager to join our team at Thermo Fisher Scientific. As a key member of our clinical operations team, you will be responsible for providing quality oversight to Contract Research Organizations (CROs) and ensuring timely delivery of quality study data.Key ResponsibilitiesProvide leadership to teams...

  • Clinical Trial Operations Manager

    4 settimane fa

    Milano, Lombardia, Italia Pharmiweb A tempo pieno

    Job DescriptionJob Title: Clinical Trial Operations ManagerJob Summary:We are seeking a highly skilled Clinical Trial Operations Manager to join our team at Pharmiweb. As a Clinical Trial Operations Manager, you will be responsible for managing the day-to-day activities of clinical trials, ensuring that they are conducted in accordance with regulatory...

  • Senior Clinical Trial Manager

    21 ore fa

    Milano, Lombardia, Italia Johnson And Johnson A tempo pieno

    Job SummaryJohnson & Johnson is seeking a highly skilled Sr. Site Manager to serve as the primary point of contact between the Sponsor and the Investigational Site for assigned clinical trials in various therapeutic areas. In this role, you will be responsible for ensuring inspection readiness and compliance with clinical trial protocols, Good Clinical...

  • Clinical Trial Manager

    3 settimane fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About the RoleWe are seeking a highly skilled Clinical Trial Manager to join our team at Thermo Fisher Scientific. As a Clinical Trial Manager, you will be responsible for leading clinical trial management, overseeing CRO deliverables, and driving innovation through technology to ensure timely delivery of quality study data.Key ResponsibilitiesProvide...

  • Clinical Trial Manager

    4 settimane fa

    Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Clinical Trial Manager (Global)Jefferson Wells è alla ricerca di un professionista esperto per ricoprire il ruolo di Clinical Trial Manager (Global).Descrizione del ruoloIl Clinical Trial Manager (Global) è responsabile della conduzione operativa di uno o più studi clinici preregistrativi. Collabora con il Clinical Scientist, il Clinical Operation Lead,...

  • Clinical Trial Manager

    3 giorni fa

    Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Inseriamo un Quadro A3 - CCNL Chimico Farmaceutico. Clinical Trial Manager (Global)Descrizione del ruoloSiamo alla ricerca di un Clinical Trial Manager (Global) per collaborare con il Clinical Scientist, il Clinical Operation Lead, con il Clinical R&D Manager e con il Clinical R&D Director alla definizione e gestione di progetti clinici di...

  • Clinical Trial Manager

    3 settimane fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job SummaryWe are seeking a highly skilled Clinical Trial Manager to lead clinical trial management from start-up to close, ensuring timely delivery of quality study data and collaborating with cross-functional teams to drive operational strategy.About the RoleThis role will be embedded within a client dedicated team, working alongside the client's own...

  • Clinical Trial Manager

    2 settimane fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About the RoleAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world a healthier, cleaner, and safer place. As a Clinical Trial Manager, you'll play a critical role in bringing our mission to life by overseeing the execution of clinical trials from start to finish.Key ResponsibilitiesProvide quality oversight to Contract...

  • Clinical Trial Manager

    3 settimane fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Unlock Meaningful Work at Thermo Fisher ScientificAt Thermo Fisher Scientific, we're driven by a shared mission to enable our customers to make the world healthier, cleaner, and safer. As a Clinical Trial Manager, you'll play a critical role in bringing this mission to life by leading the execution of clinical trials from start to finish.Key...

  • Clinical Trial Manager

    4 settimane fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Unlock Meaningful Work at Thermo Fisher ScientificAt Thermo Fisher Scientific, we're driven by a shared mission to make the world healthier, cleaner, and safer. As a Clinical Trial Manager, you'll play a pivotal role in bringing this mission to life by leading the execution of clinical trials from start to finish.Key Responsibilities:Provide quality...

  • Clinical Trial Manager

    2 mesi fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About the RoleWe are seeking a highly skilled Clinical Trial Manager to join our team at Thermo Fisher Scientific. As a key member of our clinical operations team, you will be responsible for leading and coordinating the execution of clinical trials from start-up through database close and inspection readiness.Key ResponsibilitiesProvide quality oversight to...

  • Clinical Trial Manager

    3 settimane fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Unlock Meaningful Work at Thermo Fisher ScientificAt Thermo Fisher Scientific, we're driven by a shared mission to make the world healthier, cleaner, and safer. As a Clinical Trial Manager, you'll play a pivotal role in bringing this mission to life by leading the execution of clinical trials from start to finish.Key Responsibilities:Provide quality...

  • Clinical Trial Manager

    1 mese fa

    Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Cercasi Clinical Trial Manager (Global)Jefferson Wells è alla ricerca di un professionista esperto nella conduzione di studi clinici globali. Il candidato ideale sarà responsabile della gestione operativa di uno o più studi clinici preregistrativi, lavorando in collaborazione con il Clinical Scientist, il Clinical Operation Lead, il Clinical R&D Manager e...

  • Clinical Trial Manager

    1 mese fa

    Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Cercasi Clinical Trial Manager (Global)Jefferson Wells è alla ricerca di un professionista esperto nella conduzione di studi clinici globali. Il candidato ideale sarà responsabile della gestione operativa di uno o più studi clinici preregistrativi, lavorando in collaborazione con il Clinical Scientist, il Clinical Operation Lead, il Clinical R&D Manager e...

  • Clinical Trial Manager

    4 settimane fa

    Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Clinical Trial Manager (Global)Jefferson Wells è alla ricerca di un professionista esperto nella conduzione di studi clinici. Il candidato ideale sarà responsabile della gestione operativa di uno o più studi clinici preregistrativi, lavorando in collaborazione con il Clinical Scientist, il Clinical Operation Lead, il Clinical R&D Manager e il Clinical R&D...

  • Clinical Trial Manager

    1 mese fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Unlock Meaningful Work at Thermo Fisher ScientificAt Thermo Fisher Scientific, you'll embark on a journey that makes a lasting impact on a global scale. Our mission is to empower our customers to create a healthier, cleaner, and safer world. As a key member of our team, you'll play a vital role in driving scientific innovation and advancing research.Key...

  • Clinical Trial Manager

    1 settimana fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Trial Manager, you'll play a critical role in bringing our mission to life by leading the execution of clinical trials from start to finish.Key Responsibilities:Provide quality oversight to Contract Research Organizations...

  • Clinical Trial Oversight Manager

    7 giorni fa

    Milano, Lombardia, Italia Amgen Sa A tempo pieno

    Clinical Trial Oversight ManagerAt Amgen, we are committed to serving patients through innovative biotechnology solutions. As a Clinical Trial Oversight Manager, you will play a critical role in ensuring the quality and delivery of our clinical trials. Your responsibilities will include performing sponsor oversight activities, collaborating with line...

  • Clinical Trial Manager

    1 mese fa

    Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Unlock Meaningful Work at Thermo Fisher ScientificAt Thermo Fisher Scientific, you'll embark on a journey that makes a lasting impact on a global scale. Our mission is to empower our customers to create a healthier, cleaner, and safer world. As a key member of our team, you'll play a vital role in driving scientific innovation and advancing research.Key...