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, an expert in start-up.
IQVIA's size and global footprint will present you with the breadth of opportunities necessary to develop your career.
Typically assigned to one or two projects, or a program, responsibilities might include:
Manage Clinical Team (CT) agendas, information, documentation, and team communications to ensure timely and accurate dissemination of the CT strategy and operational status throughout the cross-functional team and between co-development partners and/or other external partners as applicable. Ensure documentation of team meetings, key decisions, action items, risk, and team communication.
Partner with the Global Project Leader and Global Trial Leader, as well as the program Coordinators and Finance to support continuous forecast for the program under that Clinical Team.
Partner with cross-functional leads for the program within Global Development and outside of Global Development such as regulatory, finance, clinical supplies, Biomarker depts, and Global Medical safety to ensure appropriate communication and escalations and resolutions around risks and issues are being shared when it comes to quality, timelines, and budget.
Manage the governance infrastructure and reporting with co-development partners and/or other external partners as directed by the GPL.
Manage clinical team governance deliverables partnering with the GTLs for trial level information.
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.
Profile Required
A minimum of a bachelor's Degree or equivalent work experience is required:
Post-Graduate degree in Project Management or business is preferred.
Professional Project Management certification is preferred.
A minimum of 5 years industry/CRO/business experience is required in clinical drug development and/or clinical operations, clinical R&D experience preferred.
A minimum of 3 or more years' experience in Project Management is preferred.
Prior experience leading cross-functional global teams is required.
Demonstrated ability to resolve conflict and influence teams without direct authority.
Successful experience in planning and management of governance bodies is preferred.
Proficient in MS Project is required.
Global project management experience within the drug development industry, with previous CRO experience; familiarity with highly complex projects.
In-depth therapeutic knowledge in one of our key therapeutic areas including: Internal Medicine, Central Nervous System, Gastroenterology, Immunology & Women's Health, Cardiovascular Renal Metabolic, Early Clinical Development or Oncology; Oncology preferred.
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 at https://jobs.iqvia.com
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