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Manager Clinical Data Management

UK, PT
Full-time
Permanent employee

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.

Your profile

Education:
  • Degree in a science or related discipline.

Experience:
  • Experience of managing outsourced data management activities.
  • Experience and knowledge of benefits and pitfalls of current data collections tools and data managements methods, including approaches to risk-based centralised data monitoring.
  • Experience of phase 2-3 clinical trials.
  • Programming or Access database experience would be an advantage.

Skills/knowledge/behavioural competencies:
  • Thorough knowledge of data management and its role in the drug development process.
  • Robust knowledge of GCP and related regulatory standards for clinical data management governing clinical trials in the UK, EU & USA.
  • Excellent oral and written communication skills.
  • Highly organised, able to prioritise work, work well under pressure and meet deadlines.
  • Independent, self-starter with a proactive, problem solving approach.
  • Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
  • Ability to see complex projects to completion, and to work on a broad range of tasks within a project.

Work Location:
  • 2 days a week in our brand new Cambridge or Porto Office(s).


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