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  • Posted: Jul 14, 2021
    Deadline: Not specified
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    Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential ...
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    Senior Clinical Lead - Internal Medicine

    About the job
    Senior Clinical Lead – Internal Medicine

    The Role

    • As Senior Clinical Lead with IQVIA, you are a member of our core project team. Partnering with the Project Leader you will work strategically and collaboratively to achieve clinical operational delivery excellence, representing clinical delivery with the customer.
    • You will be responsible for running international/global studies in all therapeutic areas, managing the operational aspects of projects to meet contractual requirements. Using our innovative and cutting-edge in-house technology you’ll be key to improving the efficiency of our global trials.

    Responsibilities Overview

    Clinical Delivery

    • Partners with the Program/Project Lead to ensure timely and in scope clinical delivery.
    • Developing the monitoring plan and data cleaning strategy, including risk-based monitoring. Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums. Managing the visit report.
    • Drive patient recruitment using the most advanced technology and tools, with a data driven approach.
    • Vendor support.
    • Participating in pre-award preparation activities, attending and presenting at kick-off and investigators meetings.
    • Readily adapts to changes in project environment and able to take positive actions to minimize impact to projects. Takes responsibility for actions, projects and people.

    Project Quality

    • Developing risk mitigation and plan. Ensure timely CAPA’s and issue closure. Oversee the implementation of clinical study documents and ensure TMF inspection readiness. Provide audit support and issue management oversight

    Clinical Training and Resources

    • Responsible for clinical team resources and project related performance. Delivering project-specific trainings and providing therapeutic area training support. Creating study tools and maintaining these. Provides others with clear direction, delegates work appropriately and fosters learning and knowledge sharing between colleagues.

    Clinical and Data Management Progress

    • Drive successful data cleaning in close collaboration with Data Management. Produce clinical oversight metrics and act as clinical point of contact for the team. You will be client facing and representing clinical delivery with customers.

    Financial Support

    • Overseeing budget and variances compliance. Maintaining scope and finance systems. Responsible for tracking financial deliverables, reporting and invoicing on projects.
    • You will need to be comfortable working closely with customers and senior colleagues across the business, mentoring junior colleagues and where appropriate, influencing decision making at all levels.

    Minimum Required Education And Experience

    • Bachelor’s degree in a healthcare or other scientific discipline with at least 7 years in clinical research/monitoring experience or equivalent combination of education, training and experience. To include a minimum of 3 years leading projects (this can be as a project manager or clinical leader).

    Why Join IQVIA’s Clinical Leadership team?

    • IQVIA can offer you an unparalleled opportunity to work in one of the most dynamic clinical environments worldwide. Our systems and processes are continually developing, offering advanced analysis and data for your projects. You will have extensive opportunities to further develop your skills and we offer clear paths with which you can progress your career.
    • The CL team works in a remote but well-structured and supported environment which can offer you flexibility to work from home and manage your time effectively.

    Join us now and further your Clinical Lead career.

    At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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    GRIDDS Senior Team Lead

    About the job
    Job Overview

    • The GRIDDS (Graphical Review Interface for Dynamic Data Services) Senior Lead is responsible for coordinating programming activities for graphical data visualization though tools such as JReview and Spotfire in addition to SAS. This is a client facing role that gives the opportunity to work with a variety of functions and client groups within the organization.
    • We would expect form Senior Lead to provide experienced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving data visualization needs. Provide technical expertise and leadership to the department. Provide consulting services, including specifications and user needs analysis for project or client requirements.

    Essential Functions

    • Define the scope of work in collaboration with internal and external clients.
    • Detect errors in detail, corrects them (e.g., reviews visualizations, outputs and SAS programs to ensure quality of deliverable) and report it to appropriate personals (internal or external clients)
    • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
    • Perform and plan t
    • Provide technical expertise to develop and maintain programs to meet internal and external clients’ needs.
    • Plan and lead the development of project-related solutions as well as
    • Perform and plan: (i) the programming, testing, and documentation of programs for use in creating graphical data visualizations e.g: tables, figures, listing and patient profiles (ii) the programming of derived dataset (derived datasets) and graphical data visualizations and (iii) the programming quality control checks for the source data and report the data issues periodically.
    • The development, implementation and validation of new process technologies, macros and applications.
    • Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies
    • Directly communicate with internal and client tool users and clinical team members to ensure appropriate understanding of requirements and project timelines.
    • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
    • Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and resource forecasts for studies.
    • Lead programming teams on multiple projects and managing projects at a group level
    • Manage project budget and monthly finance activities and provide resourcing forecasts for single studies.
    • Provide training and mentoring to client and internal team members

    Required Knowledge, Skills And Abilities

    • Good verbal and written communication skills.
    • Knowledge of programming and/or clinical drug development process
    • Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
    • Ability to work on and lead multiple projects, plan, organize and prioritize activities.
    • In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Ability to independently manage multiple tasks and projects
    • Ability to delegate work to other members of the SP team
    • Excellent accuracy and attention to detail
    • Exhibits routine and occasionally complex problem-solving skills
    • Ability to lead teams and projects and capable of managing projects at a group level
    • Recognizes when negotiating skills are needed and seeks assistance.
    • Ability to estimate programming scope of work and communicate project status
    • Working knowledge of Base SAS, SAS/STAT and SAS Macro Language
    • Exhibits routine and occasionally complex problem-solving skills
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients

    Minimum Required Education And Experience

    • Master’s degree in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 5 years relevant experience; or equivalent combination of education, training and experience
    • Data Team Lead experience will be an advantage

    At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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    Clinical Project Managers, Cardiovascular Renal Metabolic

    About the job
    CVRM Senior CPM Evergreen Job Description
    **Qualified applicants will have a demonstrated background managing medium to large sized, multiple and full service, global trials in at least one of the following therapeutic areas: Cardiovascular, Renal and Metabolic/Endocrinology

    OVERVIEW:

    • IQVIAs Cardiovascular, Renal and Metabolic Unit is a global team of professionals dedicated to assisting our clients in driving healthcare forward and enabling medical breakthroughs that advance healthcare and patient treatment options around the world, We are looking for a Senior Clinical Project Manager with experience in Cardiovascular, Renal and Metabolic Diseases, experience to join our innovative and dynamic group.
    • This is an important and high-profile role within IQVIA’s CVRM Unit. Project leaders are the people who lead the delivery of our studies bringing drugs to market faster and ultimately improving patients’ lives. It is a role that requires you to liaise directly between IQVIA functions and the customer, acting as that accountable point for delivery and quality whilst maintaining financial control.
    • As a project leader you will manage cross functional teams across this global organization. You will be supported by domain experts in every function, enabled by best in class technology and data analytics. Key collaborators are the Clinical Lead for site management, the Project Management Analyst for project coordination, tracking and financial analysis, the Site Activation Manager an expert in start-up as well as the functional leads for any other contracted services. IQVIA’s size and global footprint will present you with the breadth of opportunities necessary to develop your career.

    While projects vary, your typical responsibilities might include:

    • Serving as the primary project contact with the client
    • Leading and managing cross-functional project teams to support milestone achievement
    • Project status reporting and surveillance for risk
    • Monitoring team performance against contract and client expectations and according to key performance metrics
    • Leading problem-solving including management of risk and issue resolution
    • Developing or reviewing study management plans
    • Managing team resource assignments and accountability
    • Ensure the financial success of the project
    • Oversight of database management and any other contracted services
    • Ensuring compliance with study tools, training materials and standard processes, policies, and procedures.
    • Participate in bid defense preparations and presentations in partnership with Business Development.

    Required Knowledge, Skills And Abilities

    • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • In depth therapeutic and protocol knowledge
    • Strong communication and interpersonal skills, including good command of English language
    • Strong organizational and problem-solving skills
    • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
    • Good team leadership skills
    • Effective mentoring and training skills
    • Excellent customer service skills
    • Good judgment
    • Effective presentation skills
    • Ability to manage competing priorities
    • Strong software and computer skills, including MS Office applications
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

    Minimum Required Education And Experience

    • Bachelor's degree in life sciences or related field and 7 years’ clinical research experience including 4 years’ project management experience or equivalent combination of education, training, and experience.
    • In depth therapeutic knowledge in Cardiovascular, Renal and Metabolic Diseases would be an advantage

    At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

    Method of Application

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