Senior External Data Specialist
New
F
FortreaClinical data management
Remote CanadaFull-TimeSenior
Salary85,000 - 100,000 CAD per year
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Job Details
- Languages
- Fluent in English, both written and verbal.
- Experience
- 4+ years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- Have 4+ years of experience in pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries, or equivalent education and experience.
- Have a university/college degree; relevant work experience may be accepted in lieu of degree requirements.
- Be fluent in English, written and verbal.
- Understand ICH-GCP principles.
- Be able to use standard Microsoft suite of software products.
- Bring strong organizational, planning, and critical-thinking skills.
- Have written and verbal communication skills to interact with sponsors and internal colleagues.
- Have negotiation skills for working in a global, cross-functional environment.
- Be able to manage multiple tasks and priorities under demanding conditions.
- Maintain confidentiality of data and information.
- Project management experience is strongly preferred.
- Have a basic understanding of medical terminology; this is a plus.
Responsibilities
- Develop Vendor Data Plans, obtain approvals, and file applicable documentation to the Trial Master File.
- Coordinate study expectations, milestones, deliverables, and communication with external vendors and sponsor counterparts.
- Verify that electronic vendor data transfers include protocol-specified parameters, use the correct format, and populate the designated fields and subjects.
- 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 study and vendor logs documenting data issues and track them through resolution.
- Support review of draft protocols and eCRF design, and gather feedback from study team functions on issues affecting data review or analysis.
- Obtain and QC local laboratory ranges and verify their attachment to subject results when required.
- Plan and support multiple external data management projects and provide updates to line management and stakeholders.
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