Senior Clinical Data Manager
Title : Senior Clinical Data Manager / Principal Clinical Data Manager
Company : Clinical-stage biotechnology company
Location : Germany, office based or hybrid
Apsida are working closely with an exciting German based biotechnology company with strong cash runway and interesting clinical-stage pipeline, who are growing their clinical data management team.
We are searching for an experienced Clinical Data Manager to reporting to the Head of Biostatistics and Data Management, working in pivotal trial data for an upcoming approval.
This is a great opportunity to work for a great team on key studies within their portfolio.
Key Responsibilities :
- Oversee the creation and execution of data management plans for clinical trials, ensuring compliance with industry standards and regulations
- Manage the selection and oversight of external vendors and contractors for outsourced data management tasks
- Oversee the creation, review, and maintenance of key documents relevant to data management
- Lead data management activities for regulatory submissions, including the preparation, filing, pooling and archiving of datasets, as well as supportive documentation for regulatory authorities
The Ideal Candidate :
- Minimum of 4-8 years of experience in clinical data management preferred within the CRO, biotech or pharmaceutical industry
- Industry experience in a biotech, pharmaceutical or CRO setting
- In-depth knowledge of clinical trial data management processes, standards, and regulations, including data standards in support of MAA / NDA (e.
g., CDISC, GCP, FDA / EMA guidelines)
For more details on this opportunity, please apply to this advert or contact me to learn more - [email protected]
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