Job Overview

Clinical Data Management Expertise. Oversees and coordinates Data Management activities across one or more clinical trials. Develop and maintain successful working relationships with internal team and internal and external stakeholders to ensure and maintain data integrity and quality.

Essential Functions

Provides data management support, oversight and/or accountability for one or more clinical trials.May take a leadership role with the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).With the trial customer and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical data. – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.Performs trial level oversight controls, as appropriate, as described in the oversight plan, QC process and work instructions with minimal DML direction.Creates clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.Helps plan, create and track content, format, quality, and timing of data management deliverables, including, but not limited to, Case Report Form, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.Ensures deliverables are on time.Participates in the assigned clinical working group(s) to ensure that Data Management and Therapeutic Area trial needs and deliverables are met.Helps Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.Presents and trains at investigator and monitor meetings, if needed.Takes a leadership role in creating, planning, and tracking content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.Takes a leadership role with the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met.Takes a leadership role in Identifying and communicating lessons learned, best practices and frequently asked questions at the trial level.

Qualifications

Bachelor’s degree in Life Science or related discipline.7+ years of Data Management experience, including 3-4 years as a CDM Project Lead.Proven end-to-end Data Management exposure across clinical trials.Demonstrated project management experience with the ability to lead cross-functional workstreams.Experience working in highly diverse, cross-functional, global, and multi‑regional clinical research teams.Strong ability to interpret clinical trial data and present insights/trends to study teams.Highly organized with excellent written and verbal communication skills.Fluent in English (written and spoken).

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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.