Global Clinical Project Manager
7 meses atrás
**Job Purpose**:
**As a Global Clinical Project Manager (CPM) you are responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. The Global CPM, in concert with the Director Clinical Operations, 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**:
- 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 at a sponsor or CRO company.
- 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 Cambridge or 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 communitie
-
Global Clinical Project Manager
6 meses atrás
Porto, Portugal MoonLake Immunotherapeutics Tempo inteiro**Job Purpose**: **As a Global Clinical Project Manager you are responsible for the management of all aspects of the Clinical Study Team activities for assigned clinical studies. The Global CPM, in concert with the Director Clinical Operations, is accountable for achieving successful execution and delivery of MoonLake´s clinical development team activities...
-
Global Clinical Research Associate
Há 12 horas
Porto, Porto, Portugal Tfs Healthscience Tempo inteiroOur company, TFS HealthScience, is a leading Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to facilitate their entire clinical development journey. With expertise in full service-capabilities, resourcing, and Functional Service (FSP) solutions, we are well-positioned to support our clients' goals.The role...
-
Clinical Research Associate
2 meses atrás
Porto, Portugal Tfs Healthscience Tempo inteiroTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as a Clinical Research Associate (CRA)About...
-
Clinical Project Statistician
7 meses atrás
Porto, Portugal Bespoke Recruitment Tempo inteiro**Clinical Project Statistician** **Location: CORK (hybrid) - relocation assistance available** As a Clinical Statistician, you will be a leader in our client's clinical development programs. You will understand the patient and business needs and then develop or assist in the development of protocol designs, clinical plans, and data analysis plans in...
-
Clinical Research Associate
Há 6 dias
Porto, Portugal TFS HealthScience Tempo inteiroTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as a Clinical Research Associate (CRA)About...
-
Clinical Medical Manager
6 meses atrás
Porto, Portugal knok Tempo inteiro**Learn about knok** At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing,...
-
Clinical Research Associate
6 meses atrás
Porto, Portugal knok Tempo inteiro**Learn About knok** At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognise it in every person who embraces this mission. We are rapidly growing,...
-
Chief Clinical Operations Manager
4 semanas atrás
Porto, Porto, Portugal Knokcare Tempo inteiroAt Knokcare, we are shaping the future of healthcare through digital innovation. Our mission is to provide timely access to quality care, fostering a more equal society.About the Role:As our Chief Clinical Operations Manager, you will be instrumental in driving excellence in our clinical team. Your key responsibilities include leading and coordinating a team...
-
Clinical Process Optimization Manager
Há 2 dias
Porto, Porto, Portugal Buscojobs Portugal Tempo inteiroBuscojobs Portugal is one of Europe's leading suppliers of clinical laboratory testing and medical diagnostic imaging services. We operate in 14 countries, providing a broad geographic footprint across Europe. Estimated Salary: €60,000 - €80,000 per year. As a Clinical Process Optimization Manager, you will be responsible for major functional process...
-
Clinical SAS Programmer
6 meses atrás
Porto, Portugal MoonLake Immunotherapeutics Tempo inteiro**Job Purpose**: **As the Clinical SAS programmer you will contribute to the oversight of vendor programming activities and perform exploratory analyses of completed and ongoing MoonLake sponsored clinical trials to provide insight and to ensure high quality data, datasets and statistical outputs.** **Key accountabilities**: - Oversight and review of...
-
Project Manager
2 semanas atrás
Porto, Porto, Portugal Vestas Tempo inteiroVestas is the global leader in sustainable energy solutions. As a Project Manager, you will play a key role in driving our mission to power the world's transition to renewable energy.**Job Summary:**We are seeking an experienced Project Manager to lead our Power SI project management team in Porto, Portugal. You will be responsible for coordinating and...
-
Project Manager
6 meses atrás
Porto, Portugal Bial Tempo inteiro**Join Our Mission to Improve Lives Worldwide** Reporting to the Manager, Project Management/R&D Operations, the Project Manager ensures a successful delivery of drug, discovery, and development projects - from pre-clinical to development - proactively and positively managing all stakeholders, being accountable for monitoring, timelines, risk mitigation,...
-
Global Project Manager
Há 1 mês
Porto, Porto, Portugal Vestas Tempo inteiroVestas Technology & Operations > Research & Development (R&D) > Power SI Project ManagementAs a Project Manager in Power SI Project Management, you will lead a team of highly skilled professionals in Denmark, Portugal, and Chennai, working on projects that secure stable grid connections worldwide. Our department is accountable for establishing, operating,...
-
Project Manager, Global Supply Chain
3 meses atrás
Porto, Portugal Elementis Plc Tempo inteiroThis role supports the Global Supply Chain Director to ensure the PMO functions effectively, that projects adhere to established standards, and that project managers receive the necessary support to deliver successful projects. They work in close collaboration with the supply chain project managers, subject matter experts (SMEs), and various stakeholders to...
-
Project Manager, Global Supply Chain
3 meses atrás
Porto, Portugal Elementis Plc Tempo inteiroThis role supports the Global Supply Chain Director to ensure the PMO functions effectively, that projects adhere to established standards, and that project managers receive the necessary support to deliver successful projects. They work in close collaboration with the supply chain project managers, subject matter experts (SMEs), and various stakeholders to...
-
Project Manager Officer
6 meses atrás
Porto, Portugal Unilabs Tempo inteiroWe are one of Europe’s leading suppliers of clinical laboratory testing and medical diagnostic imaging services to private and public healthcare providers, local governments, insurance companies, pharmaceutical companies and the general public. We operate laboratory and medical diagnostic imaging facilities in 14 countries: Czech Republic, Denmark,...
-
Clinical Research Physician
6 meses atrás
Porto, Portugal Bial Tempo inteiro**Join Our Mission to Improve Lives Worldwide** Designs and medically monitors clinical studies, according to the clinical development plan, in order to assure the delivery of state-of-the-art medical and scientific results, as well as safeguarding the safety, rights and welfare of study participants and the scientific integrity of research results. **The...
-
Project Manager, Business Intelligence
6 meses atrás
Porto Salvo, Portugal Novasyte Tempo inteiroCreating a healthier world IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in driving healthcare forward by pushing the boundaries of human science and data science. Our passion, innovation, collaboration and growth help our customers create a healthier...
-
Project Manager, Global Supply Chain Oversight
2 meses atrás
Porto, Porto, Portugal Elementis Plc Tempo inteiroJob Description: Project Manager, Global Supply Chain OversightJob Summary: We are seeking a highly skilled Project Manager to support the Global Supply Chain Director in overseeing the effective functioning of the Project Management Office (PMO) and ensuring that projects adhere to established standards.Key Responsibilities:Use project management tools such...
-
Project Manager, Global Supply Chain
3 meses atrás
Porto, Portugal Elementis PLC Tempo inteiroAbout Us Elementis is a global specialty chemical company, with 1,300 employees operating 17 manufacturing sites across the globe. At Elementis, we bring a distinctive combination of expertise, innovation, and teamwork to every formulation challenge. We create high-value specialty additives that enhance the performance of our customers' products and make a...