Job Purpose As a Manager Clinical Operations you are responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. You will work in concert with the Director Clinical Operations, and are 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:
To lead the clinical study team tasked with delivery of MoonLake sponsored studies
To assist in the selection of appropriate vendors for the conduct of MoonLake sponsored studies
Ensure a detailed project plan is in place for the studies and work with the CRO and MoonLake team to set priorities and manage timelines
Responsible for oversight 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.
To 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 to the Director Clinical Operations, when appropriate
Monitor the status of clinical data collection of assigned clinical studies
To develop/review study management plans ensuring Sponsor oversight of clinical studies in accordance with MoonLake procedures
To review vendor generated clinical study related documents to ensure compliance with the objectives of the study, MoonLake procedures and relevant standards
To 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
To ensure essential documents allowing the reconstruction of each study are generated, filed and maintained by or on behalf of MoonLake.
To communicate progress and identify risks and issues arising on the assigned clinical studies to the Director Clinical Operations and other MoonLake development project team members as appropriate.
To 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.
Your profile Education: Bachelor's degree in Life Sciences, Nursing or other health care professional equivalent.
Experience: Minimum of 5 years of clinical operations experience; with increasing levels of responsibility.
Skills/knowledge/behavioural competencies:
5+years of clinical project management experience on the sponsor side.
Substantial experience of managing outsourced global clinical studies.
Therapeutic experience in dermatology and rheumatology or relevant indications, ideally experience of biological therapies.
Must possess excellent communication skills and 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.
Ability to work with little or no supervision.
High attention to detail at all times.
Must have a 'one of a kind' work ethic and must exhibit a great level of self-discipline.
Work Location: 2 days a week in our brand new Porto office.
Why us? An exciting job opportunity awaits you!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
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.
Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.
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