Job Overview
Responsible for Project Management operational delivery. Serves as a key contact for internal and external business relationships. Manages the design and launch of non-standard, complex clinical research studies as assigned. Reviews processes and provides expertise to improve project execution, database design, implementation, and maintenance of Project Services systems.
Ensures work is conducted in accordance with standard operating procedures, policies, and good practices. In addition to clinical study management responsibilities, may lead or support complex laboratory startup, facility implementation, operational readiness, and business transformation initiatives requiring coordination across multiple functional teams and external partners.
Responsibilities
Study Setup and Planning
- Facilitate study setup activities, including protocol and budget review and leading study-related meetings.
- Develop and maintain project plans, milestones, risk logs, issue logs, and action trackers.
- Partner with Study Setup teams, where applicable, to ensure quality database setup and preparation of protocol-specific documentation.
- Prepare and present protocol-specific materials at kick-off and study touchpoint meetings.
- Lead the development of customer standards.
- Lead customer meetings and presentations in partnership with Facilities, Quality, Operations, and Business Development teams.
Study Activity Monitoring and Closeout
- Monitor project plans, timelines, deliverables, and study progress throughout the project lifecycle.
- Manage study documentation, including sample receipt, testing progress, reporting, and related study activities.
- Conduct meetings to support study execution and customer requirements.
- Manage study scope changes and budgets.
- Monitor study quality and service-related issues and implement changes as required.
- Develop and share lessons learned, where applicable.
Customer and Stakeholder Management
- Build and maintain customer relationships and facilitate effective communication throughout the study lifecycle.
- Collaborate with operational teams across the organization to support study delivery.
- Serve as an escalation point for study-level issues and coordinate resolution activities.
- Coordinate customer survey follow-up activities and ongoing health checks.
- Lead activities that enhance Customer Delivery Team results and strengthen customer governance.
- Serve as an escalation point for program-level issues.
Meetings, Initiatives and Training
- Represent the company at governance meetings and other internal and external meetings as required.
- Participate in audits and inspections as needed.
- Participate in process improvement projects and department initiatives.
- Provide mentoring, guidance, and training support based on experience.
- Provide feedback to management regarding team performance against contracts, customer expectations, and project plans.
Process Improvement and Special Assignments
- Act as a task owner or Subject Matter Expert, as required.
- Support department-level assignments and special projects.
Qualifications
- Bachelor's Degree in Life Sciences or a related field, or an equivalent combination of education, training, and experience.
- 5+ years of clinical or research industry experience, including at least 3 years of project management and/or project setup experience.
- Excellent interpersonal and customer management skills.
- Thorough understanding of medical and clinical research terminology.
- Thorough knowledge of project management processes, company laboratory processes, or equivalent working knowledge of laboratory operations, including kits and supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, and site alerts.
- Demonstrated computer proficiency with Microsoft Office and company systems, or experience with comparable laboratory systems.
- Experience leading large, global, and complex Phase I-IV clinical trials preferred.
- Demonstrated ability to work in a fast-paced environment with strong organizational skills and the ability to meet deadlines.
- Strong written and verbal communication skills, including a good command of the English language.
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
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.