Director, Clinical Research Operations (Office-Based, Arlington, VA) - RSS (R1068248) in Morrisville, NC bei IQVIA™

Datum der Veröffentlichung 11/13/2019

Stellenauszug

  • Mitarbeiterkategorie:
    Vollzeitbeschäftigung
  • Berufserfahrung:
    Not Specified
  • Datum der Veröffentlichung
    11/13/2019
  • Job ID:
    R1068248

Stellenbeschreibung

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.

Summary

This person is responsible for coordinating clinical studies and will lead the Clinical Team to achieve seamless management and execution of clinical trials. The Director of Clinical Operations will develop and implement clinical operations strategies, leading the execution of clinical trials, in collaboration with the Medical Director. This person will oversee coordination and management of the clinical studies. As Director of Clinical Operations, this person will work closely with the other directors on the clinical sections of Company’s work plans, funding applications and regulatory submissions.

Qualification Requirements

Education: Masters degree or MPH is required. Other equivalent or higher degrees are accepted.

Experience: at least 10 years of experience in clinical research with supervisory experience, regardless of when last degree was obtained

Language skills / other skills / mathematical skills: no change from current job description

Essential Duties and Responsibilities

Clinical Operations: Oversee planning, implementation, and reporting of clinical trials

  • Set strategy for effective operational management of clinical trials
  • Ensure clinical studies meet milestones and timelines
  • Improve efficiencies within clinical operations, including oversight of SOPs and implementation of risk evaluation and mitigation processes for clinical studies
  • Ensure clinical studies are properly resourced, managed and executed within budget
  • Participate in the design, development and review of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents and study reports
  • Identify study sites and investigators for clinical studies with Medical Director
  • Oversee planning for investigator meetings and ensure studies are monitored to industry standards including travel to sites when necessary
  • Work with Product Development group to oversee packaging, labelling, and distribution of study drug supply from manufacturer to study sites
  • Participate as required in the preparation of the clinical contribution to IND and IDE’s, Investigational Brochure, regulatory Briefing Documents, and other relevant documentation for submission to FDA and other regulatory authorities
  • Oversee electronic and paper file management, including maintenance and archiving of Trial Master Files and other clinical trial documents in compliance with applicable guidelines and regulations
  • Accountable for conduct of clinical trials in compliance with GCP and all relevant regulations, policies, and ethical standards

Contract Management: Responsible for overall oversight of sub-agreements and contracts in support of clinical trials

  • Responsible for workscope development, vendor selection, negotiations, and oversight for collaborations and services such as data management/statistical analysis, laboratory analysis
  • Technical monitor on multiple and diverse funding agreements

Funded Program Management: As member of Senior Management Team, work to facilitate communication with and reporting to project funders

  • Participate in work plan development and monitoring
  • Prepare routine reports (semi-annual and/or annual) for funders
  • Prepare presentations and participate in meetings as needed to update funders and discuss program status

Proposal Development: Collaborate with Senior Management Team to develop and submit proposals for funding

  • Provide input on study design and budget development
  • Support resource allocation

Supervise

  • Lead team of 5 to 8 people, including Project Managers, Clinical Research Associates, and support staff
  • Provide mentorship to direct reports and maintain clear communication on performance
  • Build and maintain positive team-based culture

Education / Experience

  • Master’s degree, advanced training in a scientific or a health care field preferred
  • Excellent knowledge of clinical study conduct
  • Experience managing all phases of clinical trials
  • Experience being a member of cross-functional team
  • Experience in managing vendors preferred
  • Experience developing and monitoring clinical study budgets

Skills

  • Analytical]
  • Strong management skills

Effective process and project management skills

Solution oriented

Outstanding written and verbal communication skills

Expert knowledge of clinical study conduct

Ability to multi-task

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™

QVIA 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: R1068248