Life Scientist, Computer Scientist - Clinical Data Manager (m/f/d)

Beschreibung

Clinical Data Manager

Deutschland
(Baden-Württemberg)
Biberach
Deutschland
(Rheinland-Pfalz)
Ingelheim

JOB ID: 213491
JOB LEVEL: Berufserfahrene
FUNCTIONAL AREA: Clinical Data Manager
SCHEDULE: Vollzeit

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.THE POSITIONBiostatistics and Data Sciences (BDS) is a global organization with more than 400 employees within the Human Pharma Business Unit. Working in close collaboration with other functions at Boehringer Ingelheim (BI) and external vendors we combine methodological and technical data science skills with business and scientific expertise to drive smart, timely and confident decision making at every stage of drug development, approval and access.

On our journey to transform BDS into a modern data science organization in clinical development capable to thrive in a world of rapid and continuous change, we will change our working model towards an operating model with emphasis on cross-functional and self-organized teams creating customer-validated value.

This also will be supported by development teams focusing on optimization of processes and best use of systems in the capability management area.

As a (Senior) Clinical Data Manager you are the key contact partner in cultivating the "power of data" by means of data collection/curation, data review, delivery and data standardization. You will be an active member of a BDS development team and/or of a community of practice like for data standardization or structure.

This position can be filled in Ingelheim or Biberach (Discover our site Biberach: xplorebiberach.com)

Tasks & responsibilities

You will be responsible for the quality of our clinical studies in the field of data management. Your duties in detail:

• Implementation, monitoring and supervision of data management activities within assigned clinical trials, i.e. responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs and their set-up in EDC system, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and Data Management Plans (DMPs).
• Provision of adequate sponsor oversight of data management CROs or external data providers
• Filing and archiving of trial documentation
• Creation and execution of data quality checks throughout study conduct

You will drive and support process and system optimization in the capability management area.

• Partnering with business stakeholders to identify and evaluate business needs
• Participation in global development teams to support business objectives and uncover areas for continuous process improvement
• Mapping processes to system functionality and determining ways how to best implement the process, considering a healthy balance between system capabilities and process needs
• Driving and assisting the process of getting new business process models accepted and approved
• Creating and maintaining process documentation

Requirements

• Bachelor’s/ Master’s degree (e.g. MBA, MSc) in Life Sciences, Computer Science, Software/Computer Engineering, or related. Or high-qualified/multifaceted professional qualifications with relevant professional experience
• Understanding of dependencies among interfaces
• Experience in working in/with agile teams and/or as a product owner is a plus
• Ability to independent decision making, problem solving and ownership attitude
• Knowledge in and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods and requirements is a plus
• Understanding of CDISC standards (CDASH, SDTM, etc.…) is a plus
• Excellent communication and fluency in English in speaking and writing

EFFECTS OF COVID-19

We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.WHY BOEHRINGER INGELHEIM?This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.