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Clinical Data Manager

Remote: 
Full Remote
Experience: 
Expert & Leadership (>10 years)
Work from: 
Connecticut (USA), Illinois (USA)

Offer summary

Qualifications:

Doctorate/Master's/Bachelor's/Associate's Degree with years of experience, Degree in life science, computer science, or related field.

Key responsabilities:

  • Coordinate and oversee DM tasks
  • Ensure quality control checks and training
  • Lead submission activities and audits
  • Review and implement processes/policies/SOPs
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
See more Katalyst HealthCares & Life Sciences offers

Job description

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.).

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Quality Control
  • Verbal Communication Skills
  • Problem Solving
  • Plan Execution
  • Leadership
  • Detail Oriented
  • Teamwork

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