RWE - Site Mgr 2 (R1085887) in Durham, NC at IQVIA™

Date Posted: 9/29/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    9/29/2019
  • Job ID:
    R1085887

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics 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. Workload will include more 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.
- 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 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 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 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
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

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

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: R1085887