Director, Data Management

Director, Data Management
  • Competitive
    HOUR
  • Temporary
  • Raleigh NC, US Raleigh WAKE US 27612
Job Ref: JO000115645
Sector: Clinical
Sub-sector: Biometrics
Date Added: 19 April 2021


Director - Clinical Data Management (REMOTE)
SRG is looking for a Director - Clinical Data Management for our client that is focused on improving the scientific accuracy of analgesic programs. This person will be a key leader on the team who will be responsible for the development and communication of the operational roadmap for the CDM function.

Primary Responsibilities:

  • Coach: Approximately 75% of the time will be spent coaching and managing the team as they manage the studies. This person will need to successfully collaborate with other departments / managers in order to ensure success.
  • Player: Approximately 25% of the time will be spent as a player - not managing studies, but jumping in to help as needed.
  • Establish CDM processes including SOPs to ensure highest data quality / integrity and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices.
  • Lead or direct CDM activities including CRF / eCRF design, validation programming, discrepancy management and database development and production.
  • Ensure all CDM documentation are complete, accurate and in an inspection-ready state.
  • Ensure vendors, suppliers, & internal staff meet the highest quality standards per SOPs
  • Lead strategic decision-making process involving data management issues for ongoing clinical trials
  • Provide career development and performance management of individual employees
  • Manage escalated conflict resolution through open communication, teamwork, diplomacy, & mediation.
  • Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, technology advances, & quality assurance.

Requirements:

  • Minimum of 5 years of Clinical Data Management experience
  • Minimum 3 years of experience in a leadership position within Clinical Data Management
  • Hands - On experience with Veeva Vault required

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
31/05/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Melissa Rodrigues

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