At a Glance
- Tasks: Manage clinical study teams and ensure successful execution of clinical studies.
- Company: Innovative biotech company focused on transforming global healthcare.
- Benefits: Flexible work environment, career growth opportunities, and a supportive learning culture.
- Other info: Work hybrid in a brand new office with potential for travel.
- Why this job: Make a real impact in healthcare while working with experienced professionals.
- Qualifications: Bachelor’s degree in Life Sciences and 3+ years of clinical project management experience.
The predicted salary is between 50000 - 60000 € per year.
As Manager Clinical Operations you will be responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. This role is accountable for achieving successful execution and delivery of MoonLake’s clinical development team activities at the study level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.
Key Accountabilities
- 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.
- Responsible for oversight of elements of assigned clinical studies ensuring they are conducted in compliance with the 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 escalate 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 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 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.
Profile
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 of managing outsourced global clinical studies.
- Therapeutic experience in dermatology and rheumatology or relevant indications; experience with biological therapies would be an advantage.
Skills, Knowledge and Behavioural Competencies
- Must possess excellent communication skills and be able to effectively convey messages across to both internal and external study team members.
- Highly organised, able to prioritise work, work well under pressure and meet deadlines.
- Independent, self-starter with a proactive, problem-solving approach.
- High attention to detail.
- Must have a ‘one of a kind’ work ethic and exhibit a high level of self-discipline.
Work Location
2 days a week in our brand new Cambridge or Porto office. Some travel may be required.
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.
Manager Clinical Operations employer: MoonLake Immunotherapeutics (NASDAQ: MLTX)
MoonLake is an exceptional employer, offering a dynamic and supportive environment for the Manager Clinical Operations role. With a focus on impactful work in the biotech sector, employees benefit from a flexible hybrid work model, opportunities for professional growth, and the chance to contribute to transformative healthcare projects. Our brand new offices in Cambridge and Porto foster collaboration and innovation, making it an ideal place for those seeking meaningful and rewarding employment.
Contact Detail:
MoonLake Immunotherapeutics (NASDAQ: MLTX) Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land Manager Clinical Operations
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations field, especially those who have experience with studies similar to what MoonLake is doing. A friendly chat can lead to insider info or even a referral!
✨Tip Number 2
Prepare for interviews by diving deep into MoonLake’s projects and values. Show us you’re not just another candidate; demonstrate how your experience aligns with our mission and the specific needs of the role.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop us a quick thank-you email. It shows your enthusiasm and keeps you fresh in our minds as we make decisions.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of the MoonLake team.
We think you need these skills to ace Manager Clinical Operations
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Manager Clinical Operations role. Highlight your relevant experience in clinical project management and any specific therapeutic areas you've worked in, like dermatology or rheumatology. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our team at MoonLake. Be sure to mention any experience you have with vendor management and compliance, as these are key aspects of the job.
Showcase Your Communication Skills:Since excellent communication is crucial for this role, make sure your application reflects that. Use clear and concise language, and don’t hesitate to share examples of how you've effectively communicated with teams or vendors in the past. We love seeing those skills in action!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about MoonLake and what we stand for!
How to prepare for a job interview at MoonLake Immunotherapeutics (NASDAQ: MLTX)
✨Know Your Stuff
Make sure you’re well-versed in clinical operations and the specifics of the role. Brush up on your knowledge of clinical study management, vendor oversight, and compliance with protocols. This will not only show your expertise but also your genuine interest in the position.
✨Showcase Your Experience
Prepare to discuss your previous experience in managing clinical studies, especially any relevant work in dermatology or rheumatology. Be ready to share specific examples of how you’ve successfully navigated challenges in past projects, as this will demonstrate your problem-solving skills.
✨Ask Smart Questions
Come prepared with insightful questions about MoonLake’s clinical studies and their approach to project management. This shows that you’re engaged and thinking critically about how you can contribute to their goals. It’s also a great way to assess if the company aligns with your values.
✨Demonstrate Your Communication Skills
Since excellent communication is key for this role, practice articulating your thoughts clearly and concisely. During the interview, focus on how you convey messages and collaborate with team members, as this will highlight your fit for the collaborative nature of the job.
