RWE Senior Site Management Lead en Madrid

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.

Senior Site Management Lead opportunity

Flexible homebased position across Europe

IQVIA™ Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers and patients. IQVIA’s Real World Evidence Solutions (RWES) group is recruiting Real World Evidence Associate Site Management Leads (ASML) who are the responsible of having the clinical oversight of a project and have a key lead role by coordinating CRAs and SMs regionally and cross-regions from the start to the close-out of the project. They are RWE Physician Initiated Data Generation experts and they apply clinical research experience and skills to engage site management/monitoring staff to ensure process and practice methodology is applied consistently and in accordance with project scope and budget, SOPs, policies, good clinical practices and applicable regulatory requirements. 

PURPOSE

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.

RESPONSIBILITIES

• 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 defenses.
• 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 coworkers, managers and clients.

 Next Steps:

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.

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™