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Project Management Analyst, Real World Evidence (PMA- RWE)

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Primary Location: Sofia, Bulgaria Additonal Locations: Bratislava, Slovakia,SVK Full time R1282595

Job description

We are looking Project Management Analysts to join our innovative and dynamic Real-World Evidence (RWE) Project Management Group of global professionals dedicated to assisting our clients in driving healthcare forward.

Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The PMA works in partnership with the Project Leader (PL)/Clinical Project Manager (CPM) providing support with project management activities to mitigate risk, control cost, manage project schedule,

and ensure customer satisfaction related to assigned project/s. To be considered you must possess some previous experience with project support in the CRO industry.

IQVIA™ Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers, and patients. Our approach is unique in the industry and is defining the way companies can develop and apply real-world evidence to provide deeper insight about market dynamics, therapy area changes, outcomes research and other scientific insights.

In return the size and scope of IQVIA™ will allow you to experience rapid personal development across global studies enjoying a varied, busy, and sometimes demanding schedule.  You’ll also have dedicated support to develop your IQVIA career.

Essential Functions

• Establish and manage performance dashboards, analyze event triggers/alerts and determine appropriate follow up for Project Leader (PL) or other function(s) to act upon.
• Coordinate project schedule and ensure timely updates of all key milestone and partner with PL on related calls.
• Coordinate and support the risk and issue management process.
• Manage all aspects of the Project Finances including Estimate at Completion (EAC), monthly expenses, invoices and reconciliation.
• Demonstrate compliance with the Vendor and Purchase Order (PO) Management process.
• Implement and maintain baseline and change control processes.
• Ensure PL has timely and accurate data on areas including cost, schedule, scope, utilization, change orders and quality to support better decision-making.
• Develop and maintain relevant sections of Project Management Plans.
• Review and support project resource allocation within project budgeted for assigned portfolio/ projects.
• Prepare correspondence, including meeting minutes, for project team and/or customer.
• Organize and partner with PL in managing internal project team and customer meetings.
• Prepare project status reports and presentation materials for internal project team and customer meetings.
• Manage and coordinate core file reviews and support audits as needed. Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality.
• Manage project specific e-Training and oversee compliance.
• Coordinate and support onboarding of new Key Project Team Members and system access.
• Monitor project metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.
• Participate in regional initiatives to support Project Management Analyst (PMA) community and aid personal development.

Requirements

• Bachelor's Degree Life sciences or other related field.
• Minimum of 2 years prior clinical research experience in Project Management within a CRO environment or equivalent combination of education, training, and experience.
• Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct.
• IT skills - good software and computer skills, including Microsoft Office applications, including but not limited to, Microsoft Word, Excel, and PowerPoint.
• IQVIA Core Competencies - ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

Location: Bulgaria and Slovakia

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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