RWE - Assoc Site Management Lead

Job Overview
Lead the execution of the Site & Patient Services (SPS) components of Real World Late Phase Research (RLWPR) studies by applying clinical research expertise, exceptional decision-making skills and innovative approaches to problem solving.

Proactively set project goals and tangible expectations for SPS project team members.

Essential Functions

- Oversee the work of assigned site management staff, providing advice and guidance to help achieve quality deliverable on site.
- Assist with the development of Site Recruitment, SPS Operations and SPS Risk Management Plans.
- Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per contract.
- Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
- Manage and follow study activities through ongoing tracking and review of study progress. Report progress to appropriate SPS management and project management leaders.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Provide input and updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables.
- Act as the first line of escalation for site management questions and issues for their assigned projects
- Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
- May act as site visit report reviewer.
- May conduct monitoring and/or assessment visits as needed to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.

Requirements:
• Life sciences educational background
• Prior experience and knowledge of clinical operations – monitoring processes, documentation, GCP standards
• Skill in understanding and executing complex study designs.
• Advanced English skills
• Demonstrated team leadership and mentoring skills.
• Demonstrated ability to develop and deliver project and functional training.
• Excellent planning, organizational and problem-solving skills.
• Ability to manage competing priorities and ensure on time, high quality delivery of project tasks/responsibilities.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.