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We are seeking an experienced Clinical Data Manager to join our Clinical Operations team. In this pivotal role, you will oversee and manage fully outsourced data management activities to ensure high-quality, timely, and compliant clinical data to support regulatory submissions and clinical development goals. This is a new role where you will take ownership of data oversight across all clinical studies. You will collaborate closely with CROs, vendors, internal cross-functional teams, and external stakeholders to ensure data integrity and operational excellence.
Key Responsibilities
* Serve as the primary data management contact for assigned clinical studies.
* Oversee CROs and vendors to ensure timely, high-quality delivery of all data management activities in compliance with GCP, ICH, and regulatory requirements.
* Review and approve essential data management documentation, including Data Management Plans (DMPs) and validation specifications.
* Ensure efficient execution of database go-live, interim reviews, and database lock processes.
* Monitor data quality and resolve issues proactively to maintain data integrity.
* Support regulatory submissions by ensuring availability of clean, compliant datasets.
* Stay current with industry standards and regulatory trends to drive continuous improvement in data management practices.
Must Haves
* Significant clinical data management experience, preferably in a biotech or pharmaceutical environment.
* Experience overseeing fully outsourced data management with CRO oversight.
* Strong understanding of GCP, ICH guidelines, and regulatory requirements for clinical data.
* Proficiency in EDC systems (e.g., Medidata Rave, Veeva EDC, Oracle Inform) and data review tools.
Why Join Us?
* Make a significant impact in an innovative and growing biotech company.
* Collaborative and innovative work environment.
* Competitive salary and benefits package.
* Remote working with regular team meetings.
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