Job Purpose
As a Senior Manager Clinical Operations, you are responsible for managing all aspects of the Clinical Study Team activities for assigned clinical studies. You will work in concert with the Director of Clinical Operations and are accountable for successful execution and delivery of MoonLake's clinical development activities at the study level, ensuring compliance with company and regulatory requirements within time, quality, scope, and budget constraints.
Key Accountabilities
* Lead the clinical study team responsible for delivering MoonLake-sponsored studies.
* Assist in selecting appropriate vendors for conducting MoonLake-sponsored studies.
* Ensure a detailed project plan is in place; coordinate with CRO and MoonLake team to set priorities and manage timelines.
* Oversee assigned clinical studies to ensure compliance with protocols, study plans, guidelines, and contracts through regular contact with vendors and investigators.
* Perform site/vendor visits as part of Sponsor oversight.
* Monitor vendor deliverables, address quality issues, and escalate as needed.
* Monitor clinical data collection status.
* Develop and review study management plans to ensure Sponsor oversight in accordance with procedures.
* Review vendor-generated documents for compliance with study objectives, procedures, and standards.
* Act as the primary contact for study vendors, ensuring effective communication.
* Review and approve vendor responses to quality audits.
* Ensure essential documents are generated, filed, and maintained.
* Communicate progress, risks, and issues to the Clinical Operations Director and project team.
* Ensure compliance with MoonLake procedures and SOPs.
* Train and mentor junior team members as needed.
* Participate in SOP development, review, and training, and serve as a representative for internal process/system development.
Your Profile
Education: Bachelor’s degree in Life Sciences, Nursing, or related health care field.
Experience: Minimum of 5 years in clinical operations with increasing responsibility.
Skills/Knowledge/Behavioral Competencies
* Over 5 years of sponsor-side clinical project management experience.
* Experience managing outsourced global clinical studies.
* Therapeutic experience in dermatology and rheumatology, ideally with biological therapies.
* Excellent communication skills for internal and external stakeholder engagement.
* Highly organized with the ability to prioritize, work under pressure, and meet deadlines.
* Proactive, independent, problem-solving mindset.
* Attention to detail and self-discipline.
Work Location
* 2 days a week in our Cambridge or Porto office.
Why Us?
An exciting job opportunity awaits you!
MoonLake is a dynamic, innovative biotech company seeking passionate individuals to join our stellar team.
What We Offer
* Learning Environment: Grow alongside experienced professionals in a supportive biotech setting.
* Impactful Work: Contribute to groundbreaking projects transforming healthcare.
* Flexibility and Balance: Enjoy remote/hybrid work options and a healthy work-life balance.
* Career Growth: Opportunities for advancement and increased responsibilities.
Our Core Values
We seek potential MoonLakers embodying our values:
* We do Stellar Science: Innovate and deliver high-quality therapies.
* We go beyond: Be disruptive and challenge norms.
* We unlock value: Create long-term value for investors and communities.
About Us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focusing on inflammatory diseases, with a pipeline including sonelokimab. Founded in 2021, headquartered in Zug, with hubs in Cambridge & Porto. Visit www.moonlaketx.com for more information.
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