Clinical Data Manager

This is a fully remote position, open to applicants in Philippines.

📋 Description

• Provide comprehensive data management assistance to project teams, sponsors, and external vendors.

• Create specifications for electronic Case Report Forms (eCRF), including data capture screens and edit check specifications.

• Program, maintain, validate, and test clinical databases and Electronic Data Capture (EDC) systems.

• Develop guidelines for eCRF completion and prepare training materials.

• Conduct training for site users and monitors on clinical databases.

• Create data transfer agreements and specifications with external data vendors.

• Reconcile external data with EDC data and sponsor safety databases as needed.

• Assist in the development of external clinical data systems such as electronic Patient-Reported Outcomes (ePRO) and Interactive Web Response Systems (IWRS), and document/test data transfers.

• Formulate data management plans and associated documentation.

• Conduct ongoing data reviews and cleaning until database lock/close.

• Code medical terminology in clinical databases as required.

• Produce data listings and reports for data review and database closure/lock.

• Monitor study progress and provide updates on data status.

• Maintain thorough and up-to-date data management documentation in the Trial Master File (TMF).

• Activate and deactivate database users while keeping request records.

• Assist users requiring support with the EDC system.

• Archive clinical databases and related documents.

• Contribute to the writing and updating of data management Standard Operating Procedures (SOPs).

• Mentor and train a Clinical Data Coordinator.

• Supervise outsourced vendors to ensure compliance with timelines, deliverables, sponsor and protocol requirements, work orders, and SOPs.

⛳️ Requirements

• Bachelor's degree in a related field.

• A Master's degree in a related field is considered an asset.

• 5 to 10 years of experience in clinical data management within the biotechnology, pharmaceutical, or Contract Research Organization (CRO) sectors.

• Knowledge of the drug development process and relevant regulations, including Good Clinical Practices and ICH Guidelines.

• Significant experience with EDC systems and/or database structures, showcasing skills in database programming.

• Strong understanding of CDISC SDTM/CDASH standards.

• Highly organized and detail-oriented, with solid project planning and time management abilities.

• Proficient verbal and written communication skills in English.

• Excellent problem-solving capabilities.

• Capacity to thrive in a fast-paced environment and manage multiple competing priorities.

• Familiarity with MedDRA and WHODrug dictionaries.

• Good knowledge of Good Clinical Practices and relevant Health Canada and FDA regulations/guidelines.

• Must possess legal authorization to work in the Philippines.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and professional development opportunities.

• Attractive opportunities for advancement.

• Home-based work location.