Senior Clinical Data Manager

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

📋 Description

• Create and uphold Data Management Project Plans while documenting any deviations.

• Oversee daily data management operations and take ownership of deliverables for designated projects.

• Manage timelines, deliverables, status updates, project planning, progress monitoring, and reporting related to data management.

• Act as the primary liaison for data management communications, deliverables, out-of-scope requests, and any technical or procedural challenges.

• Assist with resource planning at the study level, review team member timesheets, manage client relationships, and participate in bid defense meetings, Work Orders, and Amendments.

• Provide training to clinical trial personnel on EDC systems, dataflow, and quality control procedures.

• Educate new data management team members on established processes and protocols.

• Conduct quality-control assessments of the work produced by less experienced personnel.

• Oversee the dataflow and performance of third-party vendors.

• Engage in project kick-off meetings, investigator meetings, and project management team discussions.

• Aid in client audits and regulatory inspections, addressing any findings that arise.

• Generate and maintain clinical trial Data Management Study Binders.

• Design and evaluate CRFs/eCRFs, completion instructions, annotated CRFs, and templates for source documents.

• Create and uphold data validation specifications, Data Management Plans, and Data Quality Review Plans.

• Take part in database design and EDC User Acceptance Testing activities.

• Oversee modifications to databases after going live.

• Coordinate the programming and validation of listings and summary tables.

• Review data, address and resolve queries, and support investigative sites with query resolutions.

• Conduct Serious Adverse Event reconciliation and help with discrepancies in medical coding.

• Facilitate quality control audits on assigned databases.

• Execute database soft-lock and hard-lock procedures.

• Prepare for the final archiving of data management documentation and assist the corporate archivist.

⛳️ Requirements

• A Bachelor’s or Master’s degree in health and/or pharmaceutical sciences, physical/biological sciences, or chemistry.

• A minimum of 5 years of experience in pharmaceutical clinical trial data management OR at least 2 years of experience as a Clinical Data Manager II.

• Comprehensive understanding of clinical trial data management concepts, processes, procedures, and pertinent issues.

• Familiarity with pharmaceutical clinical trial regulations, industry guidelines, conventions, and standards.

• Proven leadership skills in clinical data management activities.

• Capability to lead data management projects while maintaining high quality and customer satisfaction standards.

🏝️ Benefits

• Opportunity to work remotely from a home-based office anywhere in Taiwan in accordance with the Work from Home policy.

• Commitment to equal opportunity.

• Accommodations available for candidates with disabilities during the recruitment and selection process upon request.