Clinical Data Manager

This is a fully remote position, open to applicants in Mexico, +2 more states.

📋 Description

• Lead a small clinical study or co-lead larger studies with moderate supervision.

• Provide support for multiple clinical studies with minimal oversight.

• Oversee and manage data management activities with CROs and various vendors.

• Evaluate protocols for data collection, including the design of eCRFs and data requirements.

• Collaborate with CRAs, programmers, study managers, and statisticians regarding eCRFs and CRF guidelines.

• Create specifications for data edit checks and generate data listings.

• Coordinate the design and testing of EDC systems.

• Troubleshoot EDC system issues alongside team members.

• Develop the Data Management Plan for clinical studies.

• Review and provide insights on clinical, statistical, and vendor study documentation.

• Enter and manage data queries within EDC systems.

• Reconcile header data and Serious Adverse Events with clinical databases.

• Assist with database upgrades and migrations, including User Acceptance Testing.

• Maintain study workbooks and data management documentation.

• Execute database lock and freeze procedures.

• Participate in team meetings and share valuable input.

• Contribute to the creation of data management SOPs, work instructions, and process documents.

• Aid in training new employees and contractors.

• Work collaboratively with cross-functional teams to develop data collection strategies and address queries throughout clinical trials.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Adhere to Parexel processes, ICH-GCPs, and relevant regulations.

⛳️ Requirements

• A minimum of 5 years of experience in Data Management within the pharmaceutical/biotechnology industry or a comparable FDA-regulated environment.

• Familiarity with Phase 1–4 clinical studies.

• Demonstrated ability to perform fundamental Data Management tasks and engage with vendors.

• Knowledge of regulatory guidelines and industry standards, including ICH/FDA guidelines, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries.

• Experience in Oncology or CNS therapeutic areas is preferred.

• Previous involvement with Phase III pivotal studies is advantageous.

• Strong written and verbal communication skills in English.

• A Bachelor’s Degree in a scientific or healthcare field is required.

• A Master’s Degree is preferred.

• Familiarity with Parexel processes, ICH-GCPs, and other relevant regulations.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career growth.

• Flexible working arrangements.