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  • Posted: Nov 23, 2022
    Deadline: Not specified
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    IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to ...
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    Senior Project Leader, Gastroenterology, Immunology and Women’s Health - Global Project Leadership

    JOB DESCRIPTION

    • IQVIA’s Gastroenterology, Immunology and Women’s Health 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 Project Leader with experience in Gastroenterology, Autoimmune and Rheumatology, Dermatology, Rare Diseases, Plasma Derived Therapies or Women’s Health experience to join our innovative and dynamic group.
    • As Senior Project Leader you will manage cross functional teams and liaise directly between IQVIA functions and the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. 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 Vendor Manager, the Project Management Analyst for project coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up.

    Typically assigned to one or two projects, or a program, responsibilities might include:

    • Leading global cross-functional project team delivery, accountable for achievement of milestones and quality of contracted scope
    • Serving as the primary contact with the customer for progress and governance
    • Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures
    • Anticipating risk and implementing mitigation strategies
    • Managing study team assignments, accountability and resource requirements
    • Ensuring the study budget is managed proactively including scope changes and financial systems are accurate

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

    • Bachelor's degree in life sciences or related field
    • Global project management experience within the drug development industry, with previous CRO experience is ideal
    • Minimum 4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
    • In depth therapeutic knowledge in Gastroenterology (Irritable Bowel Disease, Pancreatitis, Ulcerative Colitis, Crohn’s Disease, Non-alcoholic steatohepatitis (NASH), Gastroesophageal Reflux Disease (GERD)), Autoimmune/Rheumatology (RA, Lupus or Osteoarthritis), Dermatology (Psoriasis, Atopic Dermatitis or Urticaria) ), Rare Diseases Plasma Derived Therapies, or Women’s Health (including Fertility; Contraception; Endometriosis, Osteoporosis) would be an advantage

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    Senior Statistical Programmer - Global BIOS

    Job Overview:

    • As a Senior Statistical Programmer, you will be given access to cutting-edge, in-house technology and opportunities to work on global projects across a variety of therapeutic areas.
    • You will provide experienced technical expertise to develop process methodology for the department to meet internal and external clients’ needs.
    • You will plan and coordinate the development of integrated programming solutions, serving the full spectrum of statistical programming needs, along with providing technical expertise and leadership to the department and provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
    • Acting as a lead on studies, you will directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines and support the training of new or junior team members. As well as, estimating programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.

    Requirements:

    • Bachelors or Masters’ in Computer Science, Mathematics or equivalent
    • 5+ years Statistical Programming experience within the Life-Science industry
    • Experience in SAS® Base, and good knowledge of SAS® graph and SAS® Macros
    • Excellent knowledge of CDISC standards (SDTM and ADaM)
    • Excellent application development skills
    • Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
    • Experience as technical team lead, directly engaging clients and coordinating tasks within a programming team
    • In-depth knowledge of applicable clinical research regulatory requirements, i.e. Good Clinical Practice
    • (GCP) and International Conference on Harmonization (ICH) guidelines
    • From camaraderie to professional development, working at IQVIA provides unique opportunities to advance your career alongside a group of diverse and talented colleagues.

    What is in it for you?

    • Global exposure
    • Variety of therapeutic areas
    • Collaborative and supportive team environment
    • Access to cutting-edge in-house technology
    • Excellent career development and progression opportunities
    • Work-Life Balance

    Method of Application

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