Sr Site Management Lead

Job Overview
Independently direct the execution of Real World studies by applying clinical research experience and decision making skills to proactively set goals and tangible expectations for project team members. The Site Management Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our Standard Operating Procedures (SOPs), policies and practices.

Essential Functions
• Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed Start Up strategy. May implement and maintain the Regulatory Start Up Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
• Manage the operational aspects of projects to achieve “right subjects” and “right data” to meet our contractual requirements.
• May participate in bid defense preparations.
• Ensure collaboration across Site Management Leads, including communication with regions and countries, to successfully deliver the agreed project scope; coach members of the team to ensure timely delivery of projects
• Develop and maintain clinical project plans, including but not limited to i. e. Clinical operations plan, Regulatory Start Up Management Plan, etc. to be incorporated into the integrated study management plan/project management plan.
• Accountable for the clinical delivery (subject recruitment, site management, data integrity) of assigned portion of clinical studies, or may be fully accountable for less complex studies per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Ensure all processes and tools are available to maximize Site Management team’s ability to monitor and secure patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject/patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment.

• Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally as required.
• Deliver the project/program according to the quality management plan. Guide Site Managers/Clinical Research Associates (CRAs) and advise on critical specific study issues.
• Manage risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies.  Partner with functional leaders in problem solving and resolution efforts.
• Serve as clinical project contact with customer where applicable and agreed with the project leader.
• Drive for high performance and efficiency of the clinical team.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Support the project leader and accountable as functional lead, in ensuring the financial success of the project.
• Ensure accurate completion and maintenance of internal systems (with emphasis on Clinical Trial Management System), databases, tracking tools, timelines and project plans with project specific information.
• Identify changes in scope and support project leader in completion of the change control process.
• Identify lessons learned and implement best practices.
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• May Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.
• May mentor and coach colleagues as required and provide technical guidance both within and outside the project. May act as Global Site Management Lead within a project.

Qualifications
• Bachelor's Degree Health care or other scientific discipline or educational equivalent
• Experience in clinical trials experience
• Skill in understanding and executing complex study designs.
• Ability to understand customer needs and appropriately influence decision making
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
• Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work; handles criticism well and learns from it
• Excellent customer service skills
• Strong software and computer skills, including MS Office applications
• Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
• Ability to manage competing priorities and ensure on-time, high quality delivery of project tasks/responsibilities.

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.