Project Management Analyst - EDC, IQVIA Biotech

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.

Job Overview

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.
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 eTraining 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.
Qualifications
• Bachelor's Degree Life sciences or other related field Req
• Typically requires 0 - 2 years of prior relevant experience.
• Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
• 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience 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.
• Communication - strong written and verbal communication skills including good command of English language.
• Problem solving - problem solving skills.
• Organisation - planning, time management and prioritization skills.
• Prioritisation - ability to handle conflicting priorities.
• Quality - attention to detail and accuracy in work.
• Results-oriented approach to work delivery and output.
• IT skills - good software and computer skills, including Microsfot Office applications, including but not limited to, Microsoft Word, Excel, and PowerPoint.
• Collaboration - ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Cross-collaboration - ability to work across geographies displaying high awareness and understanding of cultural differences.
• Effective communication - ability to influence without authority.
 

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.