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Senior Clinical Data Manager (External Data)

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

Job Description As a Senior Clinical Data Manager (External Data) working on the Clinical Data Management team, you will support clinical data managers in planning, documenting, testing, and managing external data transfers; and collaborate with vendors and cross functional teams.


* Support clinical data managers on external data transfers for multiple, complex data types (safety lab, ECG, spirometry, specialty biomarkers, imaging, etc.) * Support clinical data managers with any protocol-specified local laboratory samples collected in EDC * Interact directly with external data vendors and relevant crossfunctional team members (e.g., Clinical Pharmacology) * Ensure consistent use of standards and templates


* Maintains day-to-day contact with data managers to handle questions, troubleshoot, help resolve issues, and mitigate risks * Provides ongoing training to clinical data managers * Actively searches for solutions to reduce set-up times; tracks issues and proposes improvements * Assists data managers with specifications for conformance checks, external data edit checks, reconciliations and listings * Actively participates in study data type planning meeting * Develops data transfer specifications and data checks for new data types; works with relevant crossfunctional team members (e.g., medical directors, clinical scientists) to identify format/content * Coach clinical data managers to ensure external data is accounted for in study deliverables, milestones, and timelines * Manage study set-up in automated data download system * Performs other duties as assigned


* Thorough knowledge of end-to-end clinical trial data transfer process * In-depth knowledge of data management systems and processes, analysis and reporting principles * Experience managing local laboratory systems a plus * Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills * Innovative, takes measured risks, thinks outside the box, challenges the status quo * Comfortable with ambiguity * Excellent verbal and written communication skills * Works effectively with global teams in a diverse environment

PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Prefer B.S. (or equivalent degree) in a scientific or allied health field and 4-6 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background; Laboratory or sample management experience is a plus

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Senior Clinical Data Manager (External Data), Executive , Boston, Massachusetts

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