Clinical Data Manager - Structural Heart Trials

4C Medical Tech; Don Mariano Marcos; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

4C Medical Tech in the Philippines is seeking a Clinical Data Manager to oversee data management activities for investigational structural heart device studies. You will partner with the Principal Data Manager and cross-functional teams to ensure accurate, complete, and regulatory-ready data throughout the trial lifecycle.

You will own day-to-day data management from study start-up through database lock, supporting data cleaning, validation, and data transfers while ensuring compliance with

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Statistics, Computer Science, or related field.
• 3–6 years of experience in clinical data management, preferably in medical devices.
• Experience supporting clinical trials across data management lifecycle: database development, cleaning, query mgmt, and lock.
• Experience with EDC systems (Medidata Rave, CatchTrials) and CRF/eCRF design.
• Knowledge of CDISC standards and regulatory requirements (ICH-GCP, FDA 21 CFR Part 11).
• Strong analytical, organizational, and communication skills; ability to collaborate across teams.

Responsibilities

• Manage day-to-day clinical data activities for assigned studies.
• Develop and maintain clinical databases, eCRFs, and DM documentation.
• Perform data cleaning, query management, validation, reconciliation, and QC.
• Monitor data quality, outstanding queries, discrepancies, and timelines; escalate risks.
• Support DB lock preparation, data cleaning, reconciliation, and issue resolution.
• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, sites, and vendors.
• Support EDC system activities, including UAT and troubleshooting.
• Prepare data listings, reports, and data transfers for study reports/regulatory submissions.
• Maintain audit-ready documentation and support internal/regulatory audits.

Skills

Clinical data mgmt

EDC systems

Data validation

Data integrity

SQL

SAS

Documentation

Education

Bachelor's in Life Sciences

Master's preferred

Tools

Medidata Rave

CatchTrials

CDISC

Job description

4C Medical Tech in the Philippines is seeking a Clinical Data Manager to oversee data management activities for investigational structural heart device studies. You will partner with the Principal Data Manager and cross-functional teams to ensure accurate, complete, and regulatory-ready data throughout the trial lifecycle.

You will own day-to-day data management from study start-up through database lock, supporting data cleaning, validation, and data transfers while ensuring compliance with