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Senior Clinical Project Coordinator (Home-Based) - IQVIA Biotech

IQVIA Holdings Inc.

Various Locations

BASIC FUNCTIONS:

Provides project related support to the Project Management staff and other project team members from the proposal development through final deliverable. Provides strategic leadership, organization, training, and ongoing support to the project coordination group which includes Senior Project Coordinators, Project Coordinators, and Project Assistants.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Supports the Sr. Manager, Project Coordination/ Manager, Project Support & Coordination in the management of the Project Coordinators and Project Assistants in the implementation of tasks and responsibilities within their job description. 
  • Interview potential project coordination team candidates.  Provides recommendations to the Sr. Manager, Project Coordination/ Manager, Project Support & Coordination regarding the hiring of potential candidates.
  • Mentors and trains new in-house and remote employees in the implementation of tasks and responsibilities within their job description. 
  • Occasionally may be asked to present information or training on topics applicable to the Project Coordination team during monthly Project Coordination team meetings.
  • Responsible for the tracking, measurement, and evaluation of project metrics to implement efficiencies.   Suggests recommendations for outliers found in output.
  • Works in conjunction with Project Manager to formulate and maintain a project specific training matrix.   Communicates with training department to ensure matrix is uploaded into LMS.
  • Drives the development, printing, shipping, and tracking of study binders.
  • Responsible for coding project specific invoices and submitting for approval
  • Responsible for printing and forwarding project master file documents to the IQVIA Biotech Central File Room to ensure the project master file is current, complete, and audit ready. For those projects utilizing an electronic project master file, responsible for emailing project master file documents to the appropriate inbox.   Assists Project Manager with project master file audits and formulates recommendations for missing components.
  • Collaborates in the design, development, and maintenance of CTMS.
    • Participates in user acceptance testing (UAT).
    • Updates CTMS operations guide with project specific information.
    • Suggests system enhancements to development team.
  • Per project requirements, manages protocol deviation tracking, including client evaluation and subsequent documentation. Formulates recommendations to create efficiencies.
  • Per project requirements, develops methodology for site training documentation and interfaces with client.
  • Per project requirements, develops project specific working practices.
  • Per project requirements, oversees and delegates project specific tasks to those Project Coordinators allocated to the trial.
  • Maintains support responsibility, including scheduling, managing agenda updates, and meeting minutes for project team meetings and other meetings, as assigned.   
  • Provides project administrative support including meeting minute documentation, monthly reports, shipping, filing, tracking, and status summarization, as appropriate
  • Participate and assist in the planning and creation of client and investigator meetings and related materials  
  • Perform other duties, as required.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Adequate knowledge of the clinical research process
  • Excellent written and verbal communication skills
  • Excellent organizational and time management skill
  • Experience in a team/matrix environment
  • Demonstrated ability to form strong functional relationships, maintain a positive attitude, and ability to interact with all levels of staff to coordinate and execute study activities
  • Ability to handle multiple priorities within multiple clinical trials
  • Extensive experience with Microsoft Office

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties
  • Ability to travel nationally and internationally, as required

MINIMUM RECRUITMENT STANDARDS:

  • AA/BA/BS degree preferred and/or
  • Minimum of two (2) years of related experience in a clinical trial setting is required
  • Extensive knowledge with Microsoft Office
  • Prior experience with mentoring/training of staff is preferred
  • Ability and willingness to travel nationally and internationally as required
  • Excellent verbal and written communication skills required
  • Excellent interpersonal and organizational skills required
  • Ability to work independently, prioritize and work in a matrix team environment required
  • Computer literacy required

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.


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 posted: 2020-11-05

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