Clinical Research Associate

Ready to shape the future of clinical data standards and influence the success of global oncology studies?

Proclinical is seeking a Principal Clinical Data Standards Consultant to join a dynamic and growing team. This is a senior-level role that offers the opportunity to shape clinical data standards, influence strategy, and drive best practices across complex clinical research programs. The position is remote and focused on supporting oncology studies within a CRO environment.

In this role, you will develop and maintain data collection standards, ensure compliance with CDISC and regulatory requirements, and provide expert guidance on standards implementation. You will also have the chance to lead cross-functional initiatives, mentor junior colleagues, and contribute to governance decisions.

Responsibilities:

• Provide expert knowledge in clinical data standards domains.
• Develop, implement, and maintain data collection standards libraries.
• Ensure compliance with CDISC, sponsor, and regulatory requirements.
• Act as a subject matter expert for standards implementation and compliance.
• Define data collection strategies and standards for clinical trials.
• Identify business challenges and recommend innovative solutions.
• Drive improvements in processes, products, and services.
• Participate in standards governance and provide input on complex topics.
• Lead or contribute to departmental and cross-functional initiatives.
• Coordinate project team members when leading initiatives or projects.
• Develop training materials and reference documentation (e.g., CDASH, Controlled Terminology).
• Monitor regulatory developments, industry trends, and emerging standards.
• Mentor and provide technical guidance to junior team members.
• Build stakeholder alignment by presenting and defending recommendations.

Key Skills and Requirements:

• Degree in Life Sciences, Computer Science, or a related field.
• Strong expertise in clinical data standards, including CDASH, SDTM, and Controlled Terminology.
• In-depth understanding of FDA, EMA, and other regulatory expectations.
• Hands-on experience with EDC platforms such as Medidata Rave or Veeva Vault.
• Proven ability to analyze and resolve complex technical challenges.
• Experience leading initiatives, coordinating projects, or mentoring colleagues.
• Excellent communication, presentation, and stakeholder management skills.
• Ability to influence decisions and align stakeholders on complex topics.
• Track record of delivering high-quality outcomes aligned with organizational objectives.

Desirable:

• Advanced degree (Master's, PhD) or equivalent qualification.
• Experience developing standards content for internal libraries and sponsor-facing projects.
• Previous involvement in standards governance groups.
• Experience leading cross-functional process improvement initiatives.
  

If you are having difficulty in applying or if you have any questions, please contact Elis Jones at e.jonesproclinical.com.

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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