[O741] | Data Manager

Overview

The Junior Data Manager will support the execution and monitoring of operational activities related to data management in clinical trials, working under direct supervision. They will collaborate with the study team to ensure quality and compliance of data management processes, contributing to the successful conduct of clinical projects.

Responsibilities

• Assist all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments.
• Assist in the development of data management documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans.
• Support data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation and non-CRF data reconciliation; gather cross-functional input to create custom data review plans.
• Engage with cross-functional stakeholders (Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker / Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.) to ensure data quality and alignment.
• Assist in managing data deliverables processes, including database locks.
• Ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities.
• Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables.
• Provide solutions for data management issues that arise during study conduct.
• Support coordination of work performed by vendors / CROs as appropriate to ensure quality of product.

Qualifications

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