Project Leader, Early Clinical Development – Global Project Leadership
IQVIA’s Early Clinical Development 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 Project Leader with experience in early phase drug development from First Time in Human to Phase IIa Proof of Concept and Clinical Pharmacology studies in healthy volunteers and patients to join our innovative and dynamic group.
As Project Leader/ 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, the Project Management Analyst for project coordination, tracking and financial analysis, the CRA for site coordination, Medical Advisor for subject safety oversight and the Data Team Lead, Biostatistician and Pharmacokineticist for analysis and reporting.
This is an important and high-profile role within our Research & Development Operation and 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:
+ 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.
+ Managing the Phase I or Investigator site(s)
+ 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 2-4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
+ In depth knowledge of early phase study designs, clinical pharmacology, pharmacokinetics, pharmacodynamics and therapeutic knowledge in any of the following areas would be an advantage: neuro-degenerative, psychiatric or dermatological disorders; vaccines.
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://jobs.iqvia.com
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