Principal Data Manager

Raleigh - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

Responsibilities:

Lead the data management activities from study start-up through the entire data cleaning process until database lock to support the clinical studies.
Oversee all project related data management activities and manage project resources and timelines to ensure deliverables and targets are met.
Create data management plan edit check document and Case Report Form (CRF) completion guidelines.
Perform user acceptance testing (UAT) for Electronic Data Capture (EDC) systems.
Clean database by generating reviewing and closing query resolutions through daily Case Report Form review.
Help site support to answer study-related questions and perform EDC training as needed.
Communicate with Clinical Research Associate (CRA) sponsor and third-party vendors (such as central laboratory) to discuss study related functions.
Perform AE/SAE (Adverse Event/Serious Adverse Event) and third-party data (such as Pharmacokinetic lab and safety lab) reconciliation.
Communicate with other internal departments to maintain and track project timelines.
Perform database audit as needed lock and clinical data archive.
Perform quality control on various types of tasks such as review edit check listings and manage DM documentation and study reports.

Requirements:

Bachelors degree in science or related field or equivalent defined as a minimum of 6 years related combined experience in employment education knowledge and skills that will enable the incumbent to proficiently perform the duties of the role is required.
Minimum 6 years industry experience in clinical data management if bachelors degree; Minimum 4 years industry experience in clinical data management if masters degree.
Leadership experience gained leading projects or teams.
Strong communication and project management skills.

Responsibilities: Lead the data management activities from study start-up through the entire data cleaning process until database lock to support the clinical studies. Oversee all project related data management activities and manage project resources and timelines to ensure deliverables and target...