Associate Site Manager - Real World Evidence
IQVIA
Buenos Aires, AR
hace 13 horas
source : DirectEmployers Association

Job overviewEnsure 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.

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- 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.

  • 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.
  • Requirements- Bachelor's Degree preferably in life science, and 1 year of monitoring experience; or equivalent combination of education, training and experience- Good knowledge of applicable clinical research regulatory requirements;
  • 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- Good 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 sitesAt 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 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.EEO Minorities / Females / Protected Veterans / Disabled

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