Jobbeschreibung
Immunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit: www.imux.com .As a (Senior) Clinical Data Manager, 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. This role is perfect for a dynamic leader who thrives in a fast-paced, innovative environment and is critical in supporting the advancement of novel therapies through effective data management strategies. You will work closely with the Global Head of Biostatistics and our Clinical Development Operations colleagues, playing a key role in ensuring the integrity and quality of clinical trial data in accordance with global regulatory standards.
- 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
- Lead the creation and execution of data management strategies that comply with CDISC, GCP, and FDA/EMA guidelines.
- Manage external vendors and contractors to ensure high-quality data management services.
- Oversee the development and maintenance of key data management documents including DMPs, DVPs, and DTAs.
- Collaborate with various teams to ensure effective data flow and integrity across all stages of clinical research.
- Ensure compliance with data privacy laws such as GDPR and HIPAA.
- Lead data management for regulatory submissions, ensuring accurate and timely preparation of datasets and supporting documentation.
- Provide mentorship to junior data management staff, promoting a culture of excellence and continuous improvement.
- Bachelor's degree in a relevant field; advanced degree preferred.
- At least 4-8 years of experience in clinical data management within the CRO, biotech, or pharmaceutical industry.
- In-depth knowledge of data management processes, EDC systems, and regulatory standards.
- Experience with data visualization tools and proficiency in programming languages (e.g., SQL, SAS, R) is a plus.
- Demonstrated ability to manage multiple projects simultaneously while maintaining quality and meeting deadlines.
- Excellent leadership, communication, and collaboration skills.
- Entrepreneurial mindset with the ability to adapt to changing priorities and environments.
- A very good cultural fit with Immunic AG's team and values, along with cross-cultural experience.
- Excellent proficiency in English. German language skills are a plus.
- Preferably located in the Munich region or willing to relocate to Munich (supported by the company)
Join us and be part of a company where your work directly contributes to our mission of improving patient care through groundbreaking research. Immunic AG offers a stimulating work environment where innovation and collaboration are valued. We provide competitive compensation, comprehensive benefits, and opportunities for professional growth.
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