Principal Data Manager

Job Description

Job Description

Position OverviewThe Principal Data Manager is responsible to lead the data management activities to support multiple clinical studies. These activities include, but are not limited to, coordinating data management team for data management activities through the entire clinical trial process, performing hands-on data management tasks, managing resources and timelines, and providing guidance to less-experienced data managers.Primary Responsibilities

To perform this job successfully, incumbent must be able to satisfactorily perform the essential functions of the role without or with reasonable accommodations. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Functions :

• 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.

Qualifications Including Education, Experience, and Skills

Firma is an Equal Opportunity Employer. Firma does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.