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.
Manage the execution of the assigned multi-regional study(ies), which may include study management, clinical and other functions per Contract, from initiation through to closeout. Ensure that all study management and project deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices.
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 defense 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
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 coworkers, managers and clients.
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
Bachelor’s degree in life sciences or related field and 10 years’ clinical research experience including 6 years’ project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel.
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.
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.
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