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Senior Clinical Data Manager
Everest Clinical Research. Develop and maintain Data Management Project Plans and document deviations .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial data management, including project planning, quality control, and regulatory compliance. Proficient in leading data management activities and training personnel while ensuring adherence to industry standards and client satisfaction.
Highest-signal resume keywords
Clinical Trial Data ManagementProject PlanningQuality Control ProcessesPharmaceutical Clinical Trial RegulationsLeadership in Data Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data Management Project PlansData Validation SpecificationsEDC User Acceptance TestingDatabase ModificationsCRF/eCRF DesignData Quality Review PlansSerious Adverse Event ReconciliationQuery ResolutionData Management Study BindersThird-Party Vendor Management
Soft Skills
Client Relationship ManagementTeam LeadershipCommunication SkillsTraining and Mentoring
Tools & Technologies
EDC SystemsDataflow Management
Industry Keywords
Pharmaceutical SciencesClinical Trial RegulationsQuality Control AuditsData Management Standards
About the role
Key responsibilities & impact- Develop and maintain Data Management Project Plans and document deviations
- Lead day-to-day data management activities and own deliverables for assigned projects
- Manage data management timelines, deliverables, status reporting, project planning, progress tracking, and reporting
- Serve as primary contact for data management communications, deliverables, out-of-scope requests, and technical or procedural issues
- Assist with study-level resource planning, team member timesheet review, client relationship management, bid defense meetings, Work Orders, and Amendments
- Train clinical trial personnel on EDC systems, dataflow, and quality control processes
- Train new data management personnel on processes and procedures
- Perform quality-control reviews of less experienced personnel’s work
- Manage third-party vendor dataflow and performance
- Participate in project kick-off, investigators, and project management team meetings
- Support client audits and regulatory inspections and follow up on findings
- Create and maintain clinical trial Data Management Study Binders
- Design and review CRFs/eCRFs, completion instructions, annotated CRFs, and source document templates
- Develop and maintain data validation specifications, Data Management Plans, and Data Quality Review Plans
- Participate in database design and EDC User Acceptance Testing
- Manage post-go-live database modifications
- Coordinate programming and validation of listings and summary tables
- Review data, issue and resolve queries, and assist investigative sites with query resolution
- Perform Serious Adverse Event reconciliation and assist with medical coding discrepancies
- Support quality control audits on assigned databases
- Perform database soft-lock and hard-lock activities
- Prepare final archival of data management documentation and assist the corporate archivist
Requirements
What you’ll need- A Bachelors’ or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields
- At least 5 years of experience in pharmaceutical clinical trial data management OR at least 2 years of experience as a Clinical Data Manager II
- In-depth understanding of clinical trial data management concepts, processes, procedures, and relevant issues
- Knowledge of pharmaceutical clinical trial regulations, industry guidance, conventions, and standards
- Strong leadership in clinical data management activities
- Ability to lead data management projects and meet high quality and customer satisfaction standards
Benefits
Comp & perks- Remote work from a home-based office anywhere in Taiwan in accordance with the Work from Home policy
- Equal opportunity commitment
- Accommodations for candidates with disabilities during recruitment and selection upon request