Manager Clinical Operations

Manager Clinical Operations

Job Purpose:

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 Moon Lake’s clinical development team activities at the study level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

• Support the clinical study team tasked with delivery of Moon Lake sponsored studies.
• Assist in the selection of appropriate vendors for the conduct of Moon Lake sponsored studies.
• Contribute to the development of detailed project plans for the studies and work with the CRO and Moon Lake team to set priorities and manage timelines.
• 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 escalates 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 Moon Lake procedures.
• Review vendor-generated clinical study related documents to ensure compliance with the objectives of the study, Moon Lake 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 Moon Lake.
• Communicate progress and identify risks and issues arising on the assigned clinical studies to Manager and other Moon Lake project team members as appropriate.
• Ensure compliance with Moon Lake 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.

• Education:
  
  Bachelor’s degree in Life Sciences, Nursing or other healthcare 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, ideally experience with biological therapies would be an advantage.
• Skills/Knowledge/Behavioural
  
  Competencies:
  
  Excellent communication skills and able 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; high attention to detail; strong work ethic and self-discipline.

• 2 days a week in our brand new Cambridge or Porto office.
• Some travel may be required.

• 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.