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IQVIA Senior Site Manager 1, Real World Evidence in Cambridge, Massachusetts

PURPOSE

Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites. Workload will include complex projects.

RESPONSIBILITIES

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

  • 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.

  • 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.

  • Manage 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 assist in 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.

  • May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities. May act as point of contact for other Site Managers on the project.

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 organizational, interpersonal and problem-solving skills

  • Strong attention to detail

  • 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 3 years of monitoring experience; or equivalent combination of education, training and experience

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.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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