Senior Global Clinical Operations Lead/ Real World Evidence
Homebased or office-based flexible location across EU
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.
- 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.
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 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Life sciences educational background
- Prior experience and knowledge of clinical operations – monitoring processes, documentation, GCP standards
- Proven team management and leadership skills
- Excellent communication skills
You will be contacted by one of our recruiters to arrange a prescreen call should your background be relevant for this opportunity who will be able to give you more information on this team and the opportunity and also explain the assessment process to you for this role.
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 jobs.iqvia.com.
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