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Associate Clinical Data Manager (Remote)

Fortrea

Nouveau Remote
Remote Mid 🇬🇧 English
CDASH SDTM Clinical Data Management

Description du poste

About the role

Fortrea's sponsor-dedicated Clinical Data Management team is hiring an Associate Clinical Data Manager, working remotely from an office or home in the listed countries. The role covers the full cycle of clinical data management queries in a collaborative environment with other Clinical Data Managers, Data Coordinators and Statistical Programmers.

Key responsibilities

  • Assist and lead operations alongside the Senior CDM, developing project documentation, system setup, data validation processes and procedures for junior staff.
  • Work with the Senior CDM to build study milestone timelines and follow study timelines for on-time deliverables.
  • Assist or lead internal and external data management meetings.
  • Handle proactive risk management and issue resolution or escalation related to clinical data management improvement or technology.
  • Develop an understanding of CDASH and SDTM or other recognized industry standards so the programming team can maintain consistent program-level standards.
  • Be a specialist in trial-specific data capture and standards, run lessons learned and share them across the organization.
  • Act as a team leader or mentor for Clinical Data Management colleagues and stakeholders, and take on project-level activities supporting study delivery.

Required profile

  • University or college degree in life sciences, pharmacy or a related subject, or certification in a related allied health profession; additional relevant experience may be considered in lieu of formal qualifications.
  • Experience as a Lead DM, Senior CDA or similar in early-phase trials at CRO or pharma level.
  • Excellent oral and written communication and presentation skills.

Required skills

  • In-depth knowledge of the clinical trial process, data management, clinical operations, biometrics, quality management and systems applications.
  • Working knowledge of the regulatory obligations of the CRO industry toward pharmaceutical and biotechnology companies.

What we offer

  • Permanent employment contract with career progression.
  • Highly competitive compensation with local benefits such as pension contributions, health insurance and remote working allowance.
  • Athorough onboarding with a personal mentor, flexible working hours and work-life balance.

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