Clinical Data Management Lead

16 hours ago

Reading, Reading, United Kingdom IQVIA Full time

RESPONSIBILITIES  

  • Serve as primary point of contact for customer on data management deliverables
  • Manage multiple large studies or program of studies (possibly global)
  • Provide leadership and senior support to DTLs on multiple large global programs of global studies
  • Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
  • Lead direct negotiations with customer, e.g., timelines, financial, process, resources
  • Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
  • Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
  • Serve as the escalation point for unresolved data issues
  • Ensure appropriate resources are assigned to meet project deliverables
  • Create and/or review and sign-off on all data management plan (DMP) documents
  • Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
  • Serve as Subject Matter Expert (SME)
  • Provide leadership and expertise in a specific CDM task or technology
  • Independently manage SOW/budget
  • Independently bring process improvements and solutions to the CDM team/CDM department
  • Lead a focus team or global or local best practice team
  • Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES    

  • Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
  • Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
  • Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
  • Knowledge of operating procedures and work instructions and the ability to apply them in practice
  • Knowledge of Good Clinical Practices and relevant regulatory guidelines
  • Excellent communication, interpersonal, customer service, and teamwork skills
  • Excellent organizational and problem-solving skills
  • Excellent project management skills
  • Ability to work independently
  • Comprehensive understanding of clinical drug development process
  • Ability to establish and maintain effective working relationships with co-workers, managers and customers    

MINIMUM REQUIRED EDUCATION AND EXPERIENCE     

  • Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
  • Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

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

  • Clinical Trial Lead

    2 weeks ago

    Reading, Reading, United Kingdom IQVIA Full time £60,000 - £100,000 per year

    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 early phase clinical research projects (phase I and II) in different therapeutic areas.  As...

  • Clinical Trial Lead

    16 hours ago

    Reading, Reading, United Kingdom IQVIA Full time

    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 early phase clinical research projects (phase I and II) in different therapeutic areas.  As...

  • Clinical Trial Lead

    2 weeks ago

    Reading, Reading, United Kingdom IQVIA Full time £60,000 - £100,000 per year

    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 early phase clinical research projects (phase I and II) in different therapeutic areas.As Clinical...

  • Clinical Lead

    7 hours ago

    Reading, Reading, United Kingdom Sentra Care Full time

    Clinical Lead – Community Complex CareSalary £48,000Reading & OxfordshireHybrid: 3 days community-based | 2 days from homeUK Driving Licence & Own Car RequiredSentra Careare working in partnership withour client, a recognised leader in the Community Complex Care sector, to recruit an experienced Clinical Lead to support adults and children with complex...

  • Data Management Project Leader

    2 days ago

    Reading, Reading, United Kingdom ICON plc Full time

    Data Management Project LeaderICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentData Management Project Leader (Sponsor Dedicated)UK,We are currently...

  • Data Management Project Leader

    2 days ago

    Reading, Reading, United Kingdom ICON Strategic Solutions Full time

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Data Management Project Leader (Sponsor Dedicated)UK,We are currently seeking a Program Manager,...

  • Data Management Project Leader

    3 days ago

    Reading, Reading, United Kingdom ICON plc Full time

    Data Management Project LeaderICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Data Management Project Leader (Sponsor Dedicated) UK, We are...

  • Senior Data Team Lead

    2 days ago

    Reading, Reading, United Kingdom IQVIA Full time

    Job OverviewManage and support team of Data Management professionals to efficiently produce databases that meet customer requirements.Essential FunctionsProvide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database...

  • Clinical Feasibility Analytics Manager

    11 hours ago

    Reading, Reading, United Kingdom ICON plc Full time

    Feasibility Analytics ManagerICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentAs a Feasibility Analytics Manager you will be joining the world's...

  • Clinical Monitoring Analyst

    1 week ago

    Reading, Reading, United Kingdom IQVIA Full time £40,000 - £80,000 per year

    This unique role within IQVIA lends itself to a Lead programmer on Cluepoints called Centralized Monitoring Analyst (CMA) with strong communication and organisation skills. Having experience with SAS programming is necessary.This role is part of a sponsor dedicated project where you will be working with the client directly to manage deliveries.The CMA...