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 impactful projects.
- Other info: Work in a dynamic environment with experienced professionals and a supportive culture.
- Why this job: Join a team making a real difference in healthcare with groundbreaking projects.
- Qualifications: Bachelor's degree in Life Sciences and 3+ years of clinical project management experience.
The predicted salary is between 50000 - 65000 € 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 in Cambridge employer: MoonLake Immunotherapeutics (NASDAQ: MLTX)
MoonLake is an exceptional employer that fosters a supportive and innovative biotech environment, allowing you to learn and grow alongside experienced professionals. With a focus on impactful work that has the potential to transform global healthcare, we offer flexibility through hybrid working arrangements and a clear path for career progression, ensuring a healthy work-life balance while making meaningful contributions to our team.
Contact Detail:
MoonLake Immunotherapeutics (NASDAQ: MLTX) Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land Manager Clinical Operations in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations field, especially those who have experience with dermatology and rheumatology. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your project management skills. Be ready to discuss how you've successfully managed timelines and vendor relationships in past roles. We want to hear your success stories!
✨Tip Number 3
Show off your attention to detail! During interviews, highlight specific examples where your meticulous nature helped avoid issues or improved project outcomes. This is key in clinical operations!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Manager Clinical Operations in Cambridge
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.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of how you've successfully managed clinical studies and your approach to problem-solving in high-pressure situations.
Showcase Your Communication Skills:Since communication is key in this role, make sure your application reflects your ability to convey messages clearly. Use concise language and structure your application well to demonstrate your organisational skills.
Apply Through Our Website:We encourage you to apply through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to the right people!
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 managing clinical studies, especially in dermatology or rheumatology. Be ready to share specific examples of how you’ve successfully navigated challenges, managed timelines, and ensured quality deliverables in past roles.
✨Ask Smart Questions
Come prepared with insightful questions about MoonLake’s clinical studies and their approach to project management. This demonstrates your enthusiasm for the role and helps you gauge if the company culture aligns with your values.
✨Highlight Your Communication Skills
Since this role requires excellent communication, be prepared to demonstrate how you effectively convey information to both internal teams and external vendors. Share examples of how you’ve facilitated collaboration and resolved conflicts in past projects.
