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Senior clinical data manager
Senior clinical data managerVine Resources • Australia
Senior clinical data manager

Senior clinical data manager

Vine Resources • Australia
5 days ago
Job description

Overview

Senior clinical data manager position for a fully remote US-based contract role. You will take complete ownership of Veeva-based trials and oversee data management activities across multiple clinical trials, with a focus on data quality and integrity and minimal need for micromanagement.

What you will bring

Over 10 years of experience in data management. Strong practical experience with Veeva EDC Clinical Study Build is essential (Certification is highly regarded). A comprehensive understanding of EDC systems, clinical drug development processes, and guidelines for clinical trial data management. In-depth knowledge of current industry standards such as CDISC, SDTM, and CDASH. Strong technical and system knowledge, including technology platforms and data exchange confidentiality. Proficiency in project management techniques with a track record of independent delivery. Exceptional communication skills with a focus on high responsiveness and availability on Teams and email during core business hours. Leadership, proactive risk management, negotiation, planning, prioritising, and analytical skills. The ability to work autonomously with minimal client guidance, building immediate trust with oversight members.

You will be more than just a data processor. You will be the operational face of data management for a high-profile US biotech client. The ideal candidate is a proactive communicator who takes ownership of the study to drive it to closure. You will be working independently, so the ability to instil confidence in the customer without needing regular guidance is essential. This role requires you to understand trial-level milestones deeply. You must be able to create the project plan from scratch and, crucially, negotiate timelines with stakeholders, including clinical teams when necessary. Prior expertise with the Veeva EDC environment is required.

What you will do

As a Senior Clinical Data Manager, you will be responsible for the full oversight and accountability of data management activities across multiple trials. This includes :

  • Drive trial progress proactively as the primary owner.
  • Support Trial Level Endpoint Adjudication setup and implementation.
  • Develop and update DMPs, DRPs and key documentation.
  • Build and test Veeva eCRFs and manage IRT / UAT independently.
  • Manage DTAs and external data loads.
  • Conduct AE / SAE reconciliation and Veeva query management.
  • Perform SDTM transformations and create Define XML.
  • Oversee data collection QC and quality assurance.
  • Act as primary contact and escalate risks immediately.
  • Train team members on trial processes.
  • Ensure strict SOP and documentation compliance.

Next steps

If you are a skilled and experienced Senior Clinical Data Manager with over 10 years of experience, specifically with exposure to Oncology and ideally deep expertise in Veeva, we encourage you to apply. We are looking for a proactive self-starter who is looking for a challenging and rewarding remote opportunity.

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