Job Responsibilities
* Support the clinical study team tasked with delivery of MoonLake sponsored studies.
* Assist in the selection of appropriate vendors for the conduct of MoonLake sponsored studies.
* Contribute to the development of detailed project plans for the studies and work with the CRO and MoonLake team to set priorities and manage timelines.
* Oversee elements of assigned clinical studies, ensuring they are conducted in compliance with protocol, study plans, relevant guidelines and contracts through regular vendor and/or investigator site contact.
* Perform accompanied site/vendor visits as part of Sponsor oversight.
* Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and elevate when appropriate.
* Monitor the status of clinical data collection of assigned clinical studies.
* Support the development of study management plans ensuring Sponsor oversight of clinical studies in accordance with MoonLake procedures.
* Review vendor‑generated clinical study related documents to ensure compliance with the objectives of the study, MoonLake procedures and relevant standards.
* Act as the key contact for study‑associated vendors and ensure timely and effective communication between involved parties.
* Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
* Ensure essential documents that allow the reconstruction of each study are generated, filed and maintained by or on behalf of MoonLake.
* Communicate progress and identify risks and issues arising on the assigned clinical studies to Manager and other MoonLake project team members as appropriate.
* Ensure compliance with MoonLake procedures and SOPs.
* Participate in the preparation, review, updating and training of SOPs and may serve as clinical operations representative for internal process/system development.
Qualifications
* Education: Bachelor’s degree in Life Sciences, Nursing or other health‑care professional equivalent.
* Experience: 3+ years of clinical project management experience at a sponsor or CRO company; experience managing outsourced global clinical studies; therapeutic experience in dermatology and rheumatology or related indications, with a preference for experience in biological therapies.
* Skills / Knowledge / Behavioral Competencies: Excellent communication skills, highly organized, self‑starter with a proactive problem‑solving approach, high attention to detail, strong work ethic and discipline.
Work Location
* 2 days a week in one of our brand new Cambridge or Porto offices.
* Some travel may be required.
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