IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

PURPOSE

The Virtual Trial Study lead is responsible for all virtual components of an IQVIA virtual trial. The incumbent will support the PI (Principal Investigator) and the IQVIA study team, as well as the sponsor from project planning and initiation to close out.  The ideal candidate will be responsible for the delivery of all virtual trial components (IQVIA virtual trial team, virtual trial vendors, and execution of proposed virtual trial recruitment strategies and operational plans). Additionally, they will coordinate all efforts of the virtual trial with respect to milestone achievement, managing study timelines, system set up, project issues and challenges, and ensure consistent use of study related tools and training materials and compliance with standard processes, policies and procedures.

RESPONSIBILITIES

• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Implement continuous improvement activities for assigned projects.
• Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.
• Define, develop and implement study management plans, together with team assignments and accountabilities.
• Supervise team performance against contract, customer expectations, and project baselines. Develop recommendations for issue resolution for management and Sponsors.
• Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate clinical risk.
• Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings and own the implementation of appropriate corrective action plans. Manage and oversee the escalation of findings and action plans to appropriate parties.
• Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles. Ensure that Sponsor feedback is communicated and conveyed to other functional groups and action is initiated to address.
• Participate in proposal development, influence the scope and budget development of proposals for new work, including the study management costs. Escalate out of scope requests to management.
• Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs.
• Prepare and present project information at internal and external meetings. Lead bid defence presentations in partnership with Business Development and Senior Clinical Project Management staff.
• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• In depth therapeutic and protocol knowledge
• Excellent communication and interpersonal skills, including good command of English language
• Excellent organizational and problem-solving skills
• Track record of ability to work through others to deliver results to the appropriate quality and timeline metrics
• Good team leadership skills
• Effective mentoring and training skills
• Excellent customer service skills
• Good judgment
• Effective presentation skills
• Ability to manage competing priorities
• Demonstrated ability in project financial tracking and accounting methods and skill in applying them
• Good understanding of other IQVIA functions and their inter- relationship with Clinical Project Management
• Strong software and computer skills, including MS Office applications
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's degree in life sciences or related field, with a minimum of 10 years’ experience in a Clinical Research Organization including 6 years project management in clinical operations

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.