Job Purpose
The Manager of Clinical Data Management is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and oversight of data management activities of MoonLake sponsored clinical trials.
Major Accountabilities:- Contribute to the selection and development of data collection tools for phase 3 studies, including eDC, eCOA and eDiary tools.
- Oversight and review of vendor data management activities, with accountability for study level timeliness and quality of statistical deliveries.
- Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Centralized Monitoring Plans).
- Act as key contact for data management vendors to ensure effective communication between MoonLake and the data management vendors.
- Effective and close collaboration with the other members of the clinical team, including medical directors, clinical operations, biostatistics and programming.
- Provide internal data review to identify data issues using a range of data checks and visualizations.
- Ensure essential documents are filed allowing the reconstruction of each trial are generated, filed and maintained by or on behalf of MoonLake.
- Communicate progress and identify risks and issues arising on clinical trials to the Head of Biometrics, Director of Clinical Operations and other MoonLake development team members as appropriate.
- Maintain awareness of, and ensure compliance with, MoonLake policies and procedures relating to quality standards within the Company.
Why us?
An exciting job opportunity awaits!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
What we offer:
Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.
About us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com
