Clinical Data Manager - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
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.
- 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.).
Source : Katalyst Healthcares & Life Sciences