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Associate Clinical Operations Lead, Real World Late Phase

Aplica ya
Mapa de ubicación: Sofia, Bulgaria Full time R1260639

Descripción del trabajo

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 delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.
• Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plan within the agreed project strategy.
• 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. Provide input and report progress to appropriate SPS management and project management leaders.
• Act as the first line of escalation for site management questions and issues on assigned projects.
• Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
• Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.
• Participate in business development activities such as proposal development and bid defence.
• May conduct co-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.
• May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.

• Life sciences educational background
• Prior experience and knowledge of clinical operations – monitoring processes, documentation, GCP standards
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Skill in understanding and executing complex study designs.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication skills including good command of English language
• 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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at

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