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***Real World & Late Phase - Senior Site Mgmt Lead / Site Mgmt Lead/Associate Site Mgmt Lead - Western EU based - (1519881) in Reading, UK at IQVIA™

Date Posted: 2/5/2018

Job Snapshot

Job Description

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.
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.


Job Requirements

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.
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree, preferably in a life sciences discipline, and 5 years of monitoring experience, together with proven team leadership experience; or equivalent combination of education, training and experience.
 
PHYSICAL REQUIREMENTS
  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

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™.

Job ID: 1519881