(Senior) Clinical Data Manager (m/f/x)

As a (Senior) Clinical Data Manager (m/f/x), you will spearhead the development and implementation of data management systems for our clinical trials. You'll ensure compliance with industry standards and regulatory guidelines, manage external vendors, and collaborate with cross-functional teams to facilitate seamless data collection and analysis. Support the advancement of novel therapies through effective data management strategies and work closely with the Biostatistics &amp; Data Management team, playing a key role in ensuring the integrity and quality of clinical trial data in accordance with global regulatory standards.<br> <br><ul><li>Work closely with the clinical operations team for collecting data from clinical trials and lead the oversight over clinical trials data management by vendors and CROs.</li><li>Lead the creation and execution of data management strategies that comply with CDISC, GCP, and FDA/EMA guidelines.</li><li>Manage external vendors and contractors to ensure high-quality data management services.</li><li>Oversee the development and maintenance of key data management documents including DMPs, DVPs, and DTAs.</li><li>Collaborate with various teams to ensure effective data flow and integrity across all stages of clinical research.</li><li>Ensure compliance with data privacy laws such as GDPR and HIPAA. </li><li>Lead data management for regulatory submissions, ensuring accurate and timely preparation of datasets and supporting documentation.</li><li>Provide mentorship to junior data management staff, promoting a culture of excellence and continuous improvement.</li></ul>