Data Manager, Expert in Programming, EDC Systems

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

• Conduct testing and validation of databases for EDC systems, along with associated data management reports or listings.

• Validate edit checks for EDC and SAS.

• Oversee the management and creation of EDC user accounts.

• Update and maintain documentation related to data management.

• Provide support for database specifications, database construction, and user acceptance testing.

• Enter trial-related document data into data entry systems as necessary.

• Perform medical coding as required.

• Manage, review, and monitor local and central laboratory reference ranges.

• Participate in internal and external teleconferences as needed.

• Generate and review study metric reports.

• Inform management about process obstacles and suggest potential solutions.

• Provide status updates to the Project Data Manager.

• Escalate major issues to the study team.

• Assist with study close-out activities and tasks related to the database lock checklist, including query resolution, final reconciliations, and report development.

⛳️ Requirements

• A Bachelor's Degree, ideally in Life Sciences, Computer Science, or a related scientific field.

• 4–8 years of pertinent clinical data management experience within the pharmaceutical industry, contract research organization, or similar experience in a non-clinical setting.

• Familiarity with EDC systems and related data management reports or listings.

• Experience in validating EDC and SAS edit checks.

• Proficient in database specifications, database construction, and user acceptance testing.

• Background in query management, lab reference ranges, serious adverse event reconciliation, and vendor data reconciliation.

• Experience with medical coding may be necessary.

• Capability to support multiple trials of moderate or complex nature with minimal oversight.

🏝️ Benefits

• A passionate and collaborative team of professionals in clinical research, pharmacovigilance, and quality consulting.

• A diverse and inclusive work environment where every opinion is valued.

• An opportunity to make a significant impact on patients' lives.

• Opportunities for growth and advancement.

• Flexibility with remote work arrangements.