Clinical Project Manager, Sponsor Dedicated

The Clinical Project Manager (CPM) is responsible to connect science and operations to bring studies to life through the planning and execution of one or more Medical Affairs studies, including multi-country non-interventional studies, post-marketing observational studies, as well as management and oversight of external collaborations. The CPM achieves these objectives via scientific and operational expertise, strategic thinking, a global mindset and innovative solutions to address operational risks and challenges.

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.

Responsibilities

• Responsible for planning and executing Medical Affairs studies in compliance with quality
• standards (Global Regulations, and policies and procedures).
• In partnership with the Global Therapeutic Medical/Scientific Director, the CPM is responsible
• for the development of the study protocol and associated documents (i.e., informed consent
• forms, case report forms, Clinical Study Report, publications).
• Leader of the cross functional study team, including but not limited to, leading study team
• meetings, managing the critical path, working closely with affiliates, and ensuring study
• milestones are met.
• Responsible for the vendor selection, scope of the vendor activities and oversight of vendors in
• compliance with processes and procedures and the applicable regulations.
• Responsible for generating the study related training for the study team members, study sites,
• and selected vendors.
• Responsible for regular updates to the cross-functional team and stakeholders (including
• affiliates) on study status; ensuring entries in the Clinical Trial Management System (CTMS) are
• complete and accurate and expected documents are filed in the Trial Master File (TMF).
• Proactively identify and address and/or escalate study related issues with proposed mitigation.
• Analyzes metrics and recommends appropriate action as necessary.
• Manages study budget and spend against approved budget.
• Contributes to and/or leads continuous improvement activities/projects and a team culture of
• information sharing and team building.
• May provide direct supervision to employees and oversight of contractors.

Qualifications:

• Bachelor’s Degree or international equivalent is required; degree in scientific field preferred.
• Must have at least 6 years of Pharmaceutical industry related experience or 4 years of
• experience with an advanced degree.
• Demonstrates a high level of core and technical competencies through management of various
• components of clinical studies.
• Exposure in study initiation through study completion, specifically experience with study start up and primary data analysis.
• Proven good presentation and communication skills; good project management and leadership
• skills, with proven ability to successfully facilitate cross-functional team meetings.

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.  https://

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $117,200.00 - $175,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.