Clinical Data Manager, Advisor
Santa Cruz, CA
The Clinical Data Manager, Advisor works with our clients on clinical data management technologies, processes, and standards.
The position requires significant skills in continuous improvement, project management, change management, and risk management. Additionally, the consultant will leverage interpersonal skills, and extensive clinical trials experience to mentor clients on clinical data management practices.
The consultant may oversee clinical data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and client goals.
Role and Responsibilities
- Manage and oversee data management vendors or CRO partners
- Develop data management plans that deliver accurate, timely, and consistent clinical data.
- Build, review, and maintain clinical databases, data collection tools, and applications. Create, review, and maintain study documentation, such as Case Report Forms (CRFs) and Data Transfer Agreements (DTAs).
- Contribute to protocol development and review. Compile, analyze, clean, and validate clinical trial data. Identify and resolve discrepancies and issues with clinical data.
- Develop data management reports and monitor study status to ensure timelines are met.
- Represent the data management function to key internal and external stakeholders.
- Work collaboratively with clinical research and operations team to ensure accurate and complete data collection.
- Recognized as subject matter expert and advanced individual contributor professional. Requires specialized skill sets.
- Conducts highly complex work, unsupervised and with extensive latitude for independent judgment. Education Requirements
- Bachelor’s or master’s degree (or international equivalent)
- At least 8 years of clinical data management experience
- Experience running clinical trials outsourced to a CRO as well as managed in-house
- Knowledgeable in GCP, CDISC standards, clinical trial guidelines & Data Management Best Practices
- Ability to ‘wear many hats’, and self-motivated to take on new challenges
- Track record of success in a deadline-driven and multi-task environment
- Well organized and detailed oriented