Data Management Specialist

This is a fully remote position, open to applicants anywhere in the world.

📋 Description

• Support data management operations in clinical research (Data Management);

• Develop, maintain, and oversee Excel spreadsheets, Word documents, and PowerPoint presentations;

• Prepare the Query Plan;

• Conduct database cleaning (Data Cleaning);

• Handle queries (creation, monitoring, and evaluation of responses);

• Program eCRF/IWRS using specialized software;

• Offer assistance to study users (address inquiries, create user accounts, manage EDC access);

• Generate data management documentation (e.g., DMP, UAT, DBL, User Manual, IP Dispensing Manual);

• Adhere to established deadlines for studies under your purview;

• Complete all mandatory training;

• Act as the primary contact (internal and external) for studies under your management regarding data management;

• Provide eCRF usage training upon request.

⛳️ Requirements

• Bachelor's degree in Computer Science, Information Systems, Statistics, Business Administration, health-related fields (Biomedicine, Pharmacy, Nursing, Biology, Biological Sciences) or related disciplines;

• Experience in data management for clinical research, ideally in CROs, research institutions, or the pharmaceutical sector;

• Proficiency in eCRF design and configuration (CRF design) within EDC systems;

• Background in preparing Query Plans, executing Data Cleaning, and facilitating Database Lock;

• Knowledge of the implementation and management of IWRS/IRT;

• Understanding of good clinical practices and regulatory requirements relevant to clinical research (ICH-GCP, ANVISA);

• Intermediate to advanced English proficiency for reading protocols and regulatory documents.

🏝️ Benefits

• Transportation allowance;

• Parking (subject to availability);

• Health insurance plan with no monthly premium for the employee; co-payment required for tests and consultations;

• Dental plan with employee co-payment;

• Life insurance at no cost to the employee;

• Flexible meal/food allowance;

• Pharmacy partnership/discount program;

• Partnership with SESC;

• Physical wellness program - TotalPass;

• Day off for healthcare professionals;

• Childcare assistance (as per internal policy).