Your mission
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 & Data Management team, 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.
Your profile
* 5-7+ years of experience in clinical data management within the CRO, biotech, or pharmaceutical industry; preferably in an international environment.
* 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.
* Bachelor’s degree in a relevant field; advanced degree preferred.
* Demonstrated ability to manage multiple projects simultaneously while maintaining quality and meeting deadlines.
* Excellent proficiency in English.
* Excellent attention to detail, communication, and collaboration skills.
* Entrepreneurial mindset with the ability to adapt to changing priorities and environments.
* A very good cultural fit with Immunic's team and values.
Why us?
We offer
* A permanent position in an international and highly motivated team.
* A dynamic, flexible and innovative working environment.
* Participation in our company’s success through our stock option program.
* Competitive compensation, comprehensive benefits and opportunities for professional growth.
* Further benefits that promote our employee’s health and well-being: Wellpass, OpenUp, and more.
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.
About us
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.