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Clinical Data Manager
2 months ago
Responsibilities:
Project level coordination of and day to day oversight of DM tasks including Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines and approve database locks and unlocks.
Ensure that quality control checks are occurring such that quality databases are delivered.
Develop and coordinate project level training for data management staff.
Review and approve study specific training and lead vendor results and relationship at the project level.
Communication of project level issues including processes, timelines, resourcing, performance, etc.
Review of all study level non–DM documents for awareness and project level consistency.
Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.
Requirements:
Doctorate Degree OR Master's Degree and 2 years of clinical experience OR
Bachelor's Degree and 4 years of experience OR associate's degree and 8 years of experience.
High school diploma/GED and 10 years of experience.
Degree in life science, computer science, business administration or related field.
Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry.
Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, etc.).
