About us
HMNC Brain Health defines the future of depression and anxiety therapy: We develop innovative personalized therapies with the aim of shortening the duration of treatment, improving therapy outcomes and reducing the risk of relapse. The core activities of our company are the preclinical and clinical development and commercialization of innovative drugs for depression and anxiety disorders as well as laboratory tests that help to better target antidepressants on the market.
Clinical Data Manager (m/w/d) - Fulltime
Permanent employee, Full-time · München
Your mission
HMNC Brain Health is currently looking for an experienced Clinical Data Manager who will be responsible for managing clinical data in various studies related to the development of drugs for depression. The ideal candidate will have strong skills in managing clinical data, databases, and various programming languages, as well as experience working with clinical trial teams and external partners. The candidate will also be responsible for implementing and managing the data management system, selecting appropriate software and ensuring GDPR compliance, and informed consent management.
Responsibilities:
- Implementing and managing a data management system.
- Selecting appropriate software to support data management.
- Responsible for managing, integrating and validating clinical data from multiple sources.
- Design, develop and implement data management plans (DMPs).
- Oversee and support database and eCRF designs.
- Collaborate with internal clinical study teams and external partners to ensure data management requirements are met.
- Develop reports and queries to support data analyses.
- Ensure compliance with GCP, FDA, and other relevant regulations.
- Perform quality control of data and processes, as well as corrective and preventive actions.
- Ensuring GDPR compliance for clinical trials.
- Management of the ICF process.
- Main point of contact for all data management tasks.
- Development of CRF specifications, data management and data validation plans.
- Programming with SAS and creation of data sets according to CDISC-SDTM standard.
- Quality control of eCRFs and all other data management documents and SAS programs.
- Responsibility for data management activities during the conduct of clinical trials (data cleansing, coding with MedDRA and WHO-DD, preparation of status reports, data import and migration).
- Support in the maintenance and development of internal SOPs.
Your profile
- Degree in computer science, statistics, life sciences or related field or degree as a medical documentalist, documental assistant or a degree in medical documentation.
- At least 3 - 5 years of experience in clinical data collection and management (pharmaceutical industry and/or CRO)
- Experience working with various databases and programming languages.
- Profound knowledge of SAS software and experience in working with eCRF systems (Viedoc, Trialmaster)
- In-depth knowledge of GCP and FDA guidelines and other pertinent regulations.
- In-depth knowledge of CDISC standards and their implementation.
- Excellent organizational and communication skills.
- Independent, structured and goal-oriented way of working
- Ability to work in a fast-paced and team-oriented environment.
Why us?
- An inspiring work environment in a young, motivated and international team with flat hierarchies.
- A permanent position with a competitive salary in an early stage, growing and dynamic company based in Munich.
- Multiple learning and development opportunities.
- A growing benefit portfolio including a yearly career development budget.
- Flexible and family friendly working hours with the possibility of individual solutions including remote work (Home-Office).
- Good connection to public transportation as well as a parking garage in the office building.
- We value diversity - regardless of gender, nationality, ethnic and social origin, religion/belief, physical abilities, age as well as romantic orientation and identity.