RWE Site Mgr 1 (R1075026)

Iqvia Holdings Inc Durham , NC 27701

Posted 8 months ago

Job Description:

Join us on our exciting journey! 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

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.

RESPONSIBILITIES

  • With minimal supervision, 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.

  • Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.

  • With minimal supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

  • With minimal supervision, 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.

  • With minimal supervision, 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.

  • With minimal supervision, 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Basic 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

  • Basic 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 1 year 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

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

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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.

Job ID: R1075026

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RWE Site Mgr 1 (R1075026)

Iqvia Holdings Inc