Senior clinical data manager

We're looking for a highly experienced and dedicated Senior Clinical Data Manager. This is a fully remote position based in the USA, starting in October. You'll play a crucial role in overseeing and executing data management activities for multiple clinical trials, ensuring data quality and integrity from start to finish.

What you'll bring:

Over 10 years of experience in data management.

A comprehensive understanding of EDC systems, clinical drug development processes, and guidelines for clinical trial data management.

In-depth knowledge of current industry standards (e.g., CDISC, SDTM, CDASH).

Strong technical and system knowledge, including technology platforms and data exchange confidentiality.

Proficiency in project management techniques.

Leadership, proactive communication, risk management, negotiation, planning, prioritising, and analytical skills.

Experience with Veeva EDC clinical study build is a plus, but not essential.

What you'll do:

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

• Supporting the setup and implementation of Trial Level Endpoint Adjudication
• Developing and updating key data management documentation, such as the Data Management Plan (DMP) and Data Review Plan (DRP).
• Building and testing eCRFs in Veeva, and managing IRT specifications and UAT.
• Preparing Data Transmission Agreements (DTAs) and handling external data loads.
• Conducting AE and SAE reconciliations and managing queries within Veeva.
• Preparing for and performing SDTM transformations, including creating Define XML.
• Providing oversight and performing QC for end-to-end data collection, ensuring data quality and compliance.
• Acting as the primary point of contact for trial-related discussions and highlighting risks to the Project Lead.
• Guiding and training new team members on trial processes and documentation.
• Ensuring compliance with all relevant SOPs and documentation requirements.

Ready to make an impact?

If you're a skilled and experienced Clinical Data Manager with over 10 years of experience with leading trials with some exposure to Oncology trials, ideally with experience in Veeva's Clinical Study build, looking for a challenging and rewarding remote opportunity, we encourage you to apply!


This will be a fully remote long-term contract role but will be US-based, working on EST