Clinical Data Management - Team Manager

Clinical Data Management - Team Manager

Sanofi

Marcy-l'Etoile, France

JOB PURPOSE

The CDM Team Manager is responsible for the oversight of a team of Clinical Data Managers and all their clinical trial activities and deliverables as well as their transversal activities.

The CDM Team Manager role requires a thorough understanding of clinical data, efficiency in guiding its collection, development/maintain data acquisition standards to ensure quality and regulatory compliance, oversight of its management and assurance of its integrity in the clinical trial process.

The CDM Team Manager is responsible for managing, coaching, and developing employees to ensure operational excellence through ongoing training of data management employees and/or consultants.

KEY ACCOUNTABILITIES

  • Ensures that, within his/her CDM team, clinical trials are compliant and documented as appropriate within the company operating procedures and regulatory guidelines
  • Ensures that, within his/her CDM team, the integrity and quality of the data that can be provided to Health/Regulatory authorities for submission
  • Ensures an efficient implementation and follow-up of CDM activities within the partnerships for outsourced trials. Also participates in the oversight of communication, planning, resources within the partnership in collaboration with the Partnership Manager
  • Participates in the overview of Standards activity to support the definitions and updates of Standards interacting with Standard Manager
  • Follows the Key Metrics within the CDM platform for internal/outsourced trials and ensures/supports Major Milestones achievements in a timely manner
  • Works in collaboration with Clinical Department, to contribute to budget, priorities and to allocate resources to projects in development and to support needs at clinical team level
  • Participates in the strategy/orientation definition of Data Management activities and related environments within the company
  • Works in close collaboration with Global Head CDM for budget review, resource allocation and CDM overall strategy support
  • Responsible for identifying, participating and oversighting transversal initiatives concerning continuous improvement
  • Responsible for representing CDM both internally and externally, and for analyzing current operating techniques to insure optimal usage

PROFILE

Requirements & Qualifications

  • Degree or Diploma in Health/Life Sciences, Computer Sciences or other related area
  • Extensive experience in data management in clinical/medical field (minimum 10 years of relevant industry experience)
  • Extensive experience in people management (preferably > 5 years)
  • Extensive knowledge of data management software and computing skills (e.g. Rave, EDC systems, eCOA, SAS, Data visualization)
  • Extensive experience with process development within data management

Skills

  • Fluent in French and English
  • Ability to work in a multi-cultural environment
  • Effective management skills
  • Team spirit, active listening, ability to lead working groups
  • Ability to network and communicate with various functions
  • Experience with audits and inspections
  • Excellent communication and organization skills

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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