Project Manager - Late Phase Research

The Project Manager – Late Phase Research works within a research team to design and deliver phase IV, non-interventional studies (site-based and direct-to-patient), using a light touch model. Responsible for a wide-range of activities with the internal team as well as client-facing.  Main responsibilities include overall project management, drafting proposals, protocols and operational plans, overseeing internal and external team communication, and owning operational procedures and high-level delivery to meet clients’ needs. This individual will have line management and/or mentoring responsibility for several members of the project team.

Responsibilities:

• Provides operational input into proposal development to ensure actionable, on-target and timely proposals are provided to clients; attends bid defenses.
• Authors protocols, reports and other study documents with independent, critical thinking to ensure quality deliverables.
• Creates, reviews and provides relevant epidemiologic and outcomes research input into statistical analysis plans and analysis output. 
• Leads development, implementation and maintenance of operational strategy and planning.
• Administration control of the fees and expenses during the project (travels, meetings, investigators payment).
• Oversees development of the ICF and other site facing materials.
• Develops and delivers team training.
• Participates in client and investigator meetings.
• Ensures efficient and effective delivery of site management operations.
• Monitors study logistics.
• Detects possible deviations or problems in study fieldwork and finds best solution.
• May also be responsible for acting as the Single Point of Contact for sites along with other site facing activities, reviewing and approving site visit reports and developing and managing study-level central IRB submissions.
• Collaborates internally with other functional groups, such as data generation, data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
• Manages and follows study activities through ongoing tracking and review of study progress.
• Serves as a solutions-based expert, internally and externally, by applying consultative problem-solving skills.
• May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.

Requirements:

• Bachelor’s degree or equivalent with 4+ years’ experience preferably in epidemiology or other public health discipline. Advanced degree highly preferred (Master’s/PhD).
• Knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Demonstrable competence in project management with proven time management and personal organizational skills.
• Able to manage complex relationships, juggle priorities, think critically and problem-solve
• Demonstrated team leadership and mentoring skills
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills
• Ability to manage competing priorities and ensure on-time, high quality delivery of project tasks/responsibilities.

#LI-CS2

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.