Full-Time

Associate Clinical Data Manager

Early Phase

Posted on 10/25/2024

Fortrea

Fortrea

Biotechnology
Healthcare

Junior, Mid

United Kingdom

Position can be full home-based or partially office-based anywhere in the UK.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
  • Additional relevant work experience will be considered in lieu of formal qualifications.
  • Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials at CRO/pharma level.
  • Excellent oral and written communication and presentation skills.
  • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
Responsibilities
  • Assist and lead operations team alongside Senior CDM, develop project documentation, system setup, data validation processes and procedures assigned to junior staff.
  • Work with Senior CDM to build study milestone timelines and be able to read and follow study timelines for on-time deliverables.
  • Assist or lead internal and external DM meetings.
  • Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.
  • Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
  • Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate.
  • May act as a team leaders or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
  • Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

N/A

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Simplify's Take

What believers are saying

  • Adoption of DCTs reduces costs and timelines in clinical research.
  • AI accelerates drug candidate identification and trial optimization.
  • RWE provides a competitive edge in drug development and surveillance.

What critics are saying

  • Emerging CROs in Asia offer lower-cost services, increasing competition.
  • Inflationary pressures are raising operational costs, impacting profitability.
  • Regulatory scrutiny on data privacy practices is intensifying.

What makes Fortrea unique

  • Fortrea leverages decentralized clinical trials for patient-centric research.
  • The company integrates AI to optimize drug discovery and trial designs.
  • Fortrea uses blockchain to enhance data integrity and transparency.

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