Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Manage the execution of the assigned medium to large multi regionally-based clinical study (ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverable on time and within budget and in accordance with SOPs, policies and practices.
• Manage and coordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent used of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects.
• Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
• Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to
• Report on team performance against contract, customer expectations, and project baselines to management.
• Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop 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 to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and manage study issues and obstacles.
• Provide input for the development of proposals for new work and project budgets.
• 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.
• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanies site visits and ongoing mentoring of CRA team.
• Prepare and present project information at internal and external meetings.
• Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.
• Define project workloads and assignments.
• Develop and oversee maintenance of internal databases and project plans.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• In depth knowledge of, and sill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and international Conference on Harmonization (ICH) guidelines
• In depth therapeutic and protocol knowledge
• Strong communication and interpersonal skills, including good command of English language
• Strong organizational and problem-solving skills
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics
• Good team leadership skills
• Effective mentoring and training skills
• Excellent customer service skills
• Good judgement
• Effective presentation skills
• Ability to manage competing priorities
• Strong software and computer skills, including MS Office applications
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
EEO Minorities/Females/Protected Veterans/Disabled