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Senior Manager, Clinical Operations Lead
2 months ago
We are seeking a highly experienced and skilled Senior Manager, Clinical Operations to join our team at MoonLake Immunotherapeutics. As a key member of our Clinical Operations department, you will be responsible for the management of all aspects of clinical study team activities for assigned clinical studies.
Key Responsibilities:
- Lead the clinical study team to deliver high-quality clinical studies in accordance with company and regulatory requirements.
- Develop and implement detailed project plans to ensure timely and successful execution of clinical studies.
- Collaborate with vendors and internal stakeholders to ensure compliance with study protocols, guidelines, and contracts.
- Monitor and report on the status of clinical data collection and ensure quality of vendor deliverables.
- Develop and review study management plans to ensure effective Sponsor oversight of clinical studies.
- 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 allowing 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 assigned clinical studies to the Director Clinical Operations and other MoonLake development project team members as appropriate.
- Ensure compliance with MoonLake procedures and SOPs.
- Help train/mentor more junior clinical operations team members, as required.
- Participate in the preparation, review, updating, and training of SOPs and may serve as clinical operations representative for internal process/system development.
We are looking for a highly organized and self-motivated individual with a strong background in clinical operations and project management. The ideal candidate will have:
- A Bachelor's degree in Life Sciences, Nursing, or other healthcare professional equivalent.
- Minimum of 5 years of clinical operations experience, with increasing levels of responsibility.
- Substantial experience of managing outsourced global clinical studies.
- Therapeutic experience in dermatology and rheumatology or relevant indications, ideally experience of biological therapies.
- Excellent communication skills and ability to effectively convey messages across to both internal and external study team members.
- Highly organized, able to prioritize work, work well under pressure, and meet deadlines.
- Independent, self-starter with a proactive, problem-solving approach.
- Ability to work with little or no supervision.
- High attention to detail at all times.
- A 'one of a kind' work ethic and a great level of self-discipline.
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory diseases. We are committed to creating novel therapies that elevate treatment horizons, with innovative science, and high quality, always. We are a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
We offer a learning environment where you can grow alongside experienced professionals in a supportive and innovative biotech environment. You will have the opportunity to contribute to ground-breaking projects that have the potential to transform global healthcare, while enjoying a healthy work-life balance and career growth opportunities.
