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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing external vendor data, ensuring data quality, and collaborating effectively with stakeholders. Proficient in project management and maintaining compliance with ICH-GCP principles while utilizing strong communication and organizational skills.
Highest-signal resume keywords
Vendor Data ManagementProject ManagementData Quality ReviewICH-GCP PrinciplesCommunication Skills
About the role
Key responsibilities & impact- Support the Lead Data Manager with review, maintenance, and updating of external vendor data
- Develop Vendor Data Plans, including Data Quality Review reconciliation sections, obtain approvals, and file documentation to the Trial Master File
- Collaborate with external vendors and sponsors on study expectations, milestones, deliverables, and communication
- Ensure external vendor data transfers contain protocol-specified parameters, use the correct format, and populate specified fields and subjects correctly
- Develop and document external data edit checks and reports; obtain approvals and perform QC/UAT
- Review discrepancies generated by edit checks and reports and manage queries to resolve data issues
- Maintain documentation of data issues in study and vendor logs through resolution
- Assist with review of draft protocols and eCRF design from an external data perspective
- Work with study team functions to gather feedback and address issues affecting data review or analysis
- Obtain and QC local laboratory ranges and verify normal ranges are attached correctly to subject results
- Participate in study team and department meetings
- Plan and support multiple external data management projects and provide updates to management and stakeholders
- Complete Fortrea and sponsor training and perform duties according to guidelines
- Perform other assigned duties
Requirements
What you’ll need- University/college degree in life sciences, health sciences, information technology or related subjects preferred
- Experience and/or education plus relevant work experience equating to a Bachelor’s degree accepted in lieu of a bachelor’s degree
- Relevant and equivalent experience may be accepted in lieu of educational requirements
- Fluent in English, both written and verbal
- 4+ years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries, or equivalent combination of education and experience
- Project Management experience strongly preferred
- Basic understanding of medical terminology a plus
- Strong organizational, planning, and critical-thinking skills
- Well-polished, inclusive, and engaging written and verbal communication skills
- Strong negotiation skills
- Ability to handle multiple tasks in a timely and professional manner under demanding conditions
- Ability to use standard Microsoft suite of software products
- Strong technical aptitude
- Ability to maintain confidentiality of data and information
- Understanding of ICH-GCP principles
- Ability to work in a general or remote office setting
- May be required to work minimal nights and weekends to support project deadlines, milestones, and deliverables
Benefits
Comp & perks- All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data
- Remote work arrangement
- Less than 10% travel; travel is not extensive
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 Quality ReviewData ManagementEdit Checks DevelopmentQC/UATMedical Terminology UnderstandingData Issue ResolutionProtocol ReviewECRF DesignLaboratory Range VerificationDocumentation Maintenance
Soft Skills
Organizational SkillsPlanning SkillsCritical-Thinking SkillsNegotiation SkillsTime Management
Tools & Technologies
Microsoft Office Suite
Industry Keywords
Pharmaceutical IndustryBiotechnologyClinical TrialsMedical DeviceDiagnostics