Principle Clinical Data Manager
We just began working with a globally recognized, full-service clinical research organization that partners with leading pharmaceutical, biotechnology, and medical device companies to advance some of the most innovative therapies in development today. With a strong foundation in data management and biostatistics, the company has grown into a trusted CRO known for its scientific excellence, high-quality deliverables, and client-focused approach.
They are looking for a Priniciple data manager to join their team on a full time basis. This is a remote role open to anyone in thre US or Canada.
Key Responsibilites:
- Serve as the primary point of contact for all data management activities, timelines, and deliverables across assigned clinical trials.
- Lead and oversee database design, user acceptance testing (UAT), and data validation processes to ensure high-quality data outputs.
- Manage query resolution and data review across multiple sources, including medical coding and external data.
- Develop and maintain essential documentation such as the Data Management Plan (DMP) and Data Quality Review Plan (DQRP).
- Coordinate with cross-functional teams to ensure timely database lock and delivery of study reports.
- Provide training and guidance on EDC systems, data flow, and quality control processes to internal teams and study sites.
- Monitor project milestones, resource allocation, and ensure compliance with regulatory standards and SOPs.
Qualifications:
- Bachelor's or Master's degree in a life sciences or related field.
- Minimum of 7 years of clinical data management experience in a CRO or pharmaceutical environment.
- Strong leadership and project management skills with a proven ability to oversee complex clinical studies.
- Deep understanding of clinical trial data standards, regulatory requirements, and data management best practices.
- Excellent communication and collaboration skills across internal and external stakeholders.
- Proficiency in EDC systems and clinical data validation tools.
If you feel you would be a good fit, please dont hesistate to apply.
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