Offer summary

Qualifications:

Bachelor’s Degree or equivalent in clinical research or related field., At least 3 years of clinical or lab data review experience., Experience with EDC systems like RAVE, VEEVA, INFORM, or OC., Preferred experience in Oncology or Inflammatory therapeutic areas..

Key responsibilities:

Define and improve responsibilities and processes for Local Lab Handling Coordinators.

Collaborate with partners to obtain and update local laboratory information in the EDC system.

Ensure complete and accurate analyte and reference range data are available for clinical trials.

Assist in managing source documentation issues and support team members.

Job description

The Senior Local Lab Handling Coordinator is responsible for defining and continually improving the responsibilities of the Local Lab Handling Coordinators and the process for managing local laboratory information. In addition, this senior role will act as the team leader and subject matter expert for the Local Lab Handling Coordinators.

The Senior Local Lab Handling Coordinator is also responsible for collaborating with internal and external partners to obtain the information required, per the protocol, to enter local laboratory information into the EDC system. This role will also be responsible for updating local laboratory information, as needed, throughout the progression of clinical trials in the EDC system. In addition, this role work with the relevant parties to ensure that complete and accurate analyte and reference range information is available in the EDC system for clinical trials in a timely manner.

Summary of the Essential Functions of the Job

Defines the responsibilities of the Local Land Handling Coordinators as well as the process for managing local laboratory information
Receives relevant local laboratory information from investigative sites and transcribes this information into the EDC system or into a template to be imported into the EDC system
Crosschecks the information provided with the protocol to certify that all required analytes are accounted for
Works with the Clinical Data Managers (CDMs), Clinical Research Associates (CRAs) and investigative sites to clarify any source documentation issues and obtain any further updates which might be needed
Regular attendance at Clinical Data Management group meetings and any departmental trainings
Serve as a mentor to team members by guiding work, resolving challenges, and offering support

Minimum Requirements

Bachelor’s Degree or equivalent experience in clinical research or similar field
At least 3 years of clinical or lab data review experience with experience reviewing lab/analyte data and/or lab source documentation
3 years experience in Data Management - start up/lock
Third-party data recons and experience preparing DM metrics
Experience with EDC systems (RAVE/VEEVA/INFORM/OC)
Oncology and/or Inflammatory therapeutic area experience preferred

This role is not eligible for UK visa sponsorship

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $49,000.00 - $122,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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