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Senior Clinical Data Manager*

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Experience: 
Expert & Leadership (>10 years)
Work from: 

Offer summary

Qualifications:

Degree in Medical Documentation, Life Sciences or Computer Sciences, At least 10 years of experience in data management, Experience with EDC and IRT systems, Knowledge of CDISC, ICH-GCP, FDA and EMA regulations.

Key responsabilities:

  • Plan, set-up and close-out clinical trial data management activities
  • Deliver high quality data while ensuring TMF filing is inspection ready
Immatics logo
Immatics Biotech: Biology + Technology SME https://www.immatics.com/

Job description

Overview
We are currently seeking full-time a Senior Clinical Data Manager* to support our global team. You will work in Tübingen, Munich or remote (Germany) in an interdisciplinary environment with colleagues from Tübingen, Munich and Houston (USA). This permanent position is responsible for driving and managing data management activities for clinical trials.
Your mission
Your main responsibilities will include but are not limited to the following tasks:
  • Act as Project Data Manager: Plan, set-up, conduct and close-out of clinical trial data management activities within timelines and budget
  • Perform and/or oversee Data Management hands-on tasks as Trial Lead Data Manager: Preparing, reviewing releveant documents (e.g. DMP, Coding Plan, Reconciliation Plan, etc.)
  • Perform and/or oversee and manage the development, implementation and change management of clinical data management systems (e.g. eCRF, IRT, ECS, UAT Plan, UAT, Central Imaging, Central Laboratories, etc.)
  • Deliver high quality data by meeting industrial requirement and standard, timelines and milestones
  • Ensure the ongoing TMF filing to be inspection ready
  • Review and input to clinical trial documents
  • Oversee and manage centralized monitoring
  • Participate in the defninition and implementation of eCRF/IRT standards
  • Develop and maintain SOPs, guidance documents & training material for clinical data management

Your profile
You hold a degree in Medical Documentation, Life Sciences, Computer Sciences or have comparable education. You gained at least 10 years of proven experience as a lead data management for data management hands-on tasks addition to project management of data management in the pharmaceutical / biotechnology industry or a CRO. You have experience with EDC and IRT systems. Ideally you have knowledge of Rave programming, SAS/R programming, medical terminology, coding and CDISC (SDTM) expertise. 
You are familiar with ICH-GCP, FDA and EMA regulations.

For your day-to-day activities, we expect very good verbal and written English communication skills as well as a confident demeanour. You proactively drive company standards and global harmonization in the clinical data management area.
Why us?
We are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees' professional and social skills. We enable them to join conferences and trainings as well as to enjoy our Immatics benefits - e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, company summer and winter events.
Notice
*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
About us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. Operating from Tuebingen, Munich and Houston, we are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. For more detailed information, visit www.immatics.com.

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Teamwork
  • Communication

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