Senior Site Manager 3, Real World Evidence

RESPONSIBILITIES 

• May lead site selection, start-up/regulatory, remote initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions. 

• May develop or have input into project operational plans. 

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties. 

• Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology. 

• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. 

• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager. 

• Independently execute assigned work efficiently and adhere to project timelines and financial goals; may provide Site and Patient Services performance metrics and make recommendations based on their findings. 

• Drive the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. 

• May be responsible for preparation for in-house audits and in creation of Corrective Action Plans (CAPAs). 

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation. 

• Mentor less experienced clinical staff, including demonstrating appropriate interactions with sites, performing accompanied remote monitoring visits and documentation along with other monitoring activities. May act as point of contact for other Site Managers on the project. 

• May assist Site Management Lead (SML) in the development of operational plans and project-specific scripts. 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 

• Strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines 

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint 

• Strong written and verbal communication skills in applicable languages, and business level command of English 

• Strong command of financial concepts to ensure on-budget delivery of assigned studies. 

• Ability to navigate complex internal and external customer relationships to resolve issues and drive solutions 

• Working time management skills 

• Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites  

MINIMUM REQUIRED EDUCATION AND EXPERIENCE 

• Bachelor’s Degree preferably in life science, and 4 years of monitoring experience; or equivalent combination of education, training and experience 

PHYSICAL REQUIREMENTS 

• Extensive use of telephone and face to face communication requiring accurate perception of speech 

• Extensive use of keyboard requiring repetitive motion of fingers 

• Regular sitting for extended periods of time 

• May require occasional travel

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.