What do clinical project managers do?
Clinical project managers are invaluable to clinical research and project management. They ensure the successful execution of ongoing clinical trials and projects that help bring the latest medicines and clinical innovations timely and safely to the market. Sometimes the role is referred to as clinical project coordinator or clinical trial project manager.
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Clinical Director - AI
Location: North York
Branche: Life Sciences
Expertise: HR & Recruiting
Experience: 5 years
The ideal candidate is skilled in extending Large Language Models for diverse applications, handling engineering and scaling challenges in large organizations, and has a strong understanding of both biology and underlying AI algorithms. Passion for using AI to revolutionize biomedical research and unlock scientific mysteries is key to success in this role. Lead a team of AI/ML and software engineers to evaluate, develop, extend and apply advance ML/AI methods for Clinical Trial design, analysis and optimization. Develop, implement, test and refine advanced AI/ML methods for the processing, analysis, modeling integration and visualization of large-scale biomedical data including text, imaging, and omics data. Use AI and ML methods for knowledge extraction from text and other structured data and for integrating this data with other types of structure and unstructured data using multi-modal genAI methods. Be in close contact with our clinical teams to discuss requirements, possible solutions and ways to integrate the proposed AI/ML methods to improve clinical trial design and execution. Work closely with the leading generative AI companies (our vendors) to make sure our products are state of the art and up to date. Work with developers, engineers, and ML Operations to deliver AI/ML solutions to product teams.
Entwicklungsingenieur in der Medizintechnik (m/w/d)
Location: Würzburg
Branche: Medical devices
Expertise: Research & Development
Experience: 2 years
Sie übernehmen Verantwortung für die Prozesse des Risikomanagements und der klinischen Bewertung incl. Post Market Surveilance und Vigilance. Sie betreiben aktive Marktbeobachtung unserer Produkte und deren Umfeld (Post Market Surveilance), inklusive klinischer Nachbeobachtung (Post Market Clinical Follow-up). Sie übernehmen die Planung, Erstellung und Aktualisierung von klinischen Bewertungen Sie führen Literaturrecherchen durch, sammeln und werten klinische Daten aus. Sie sind verantwortlich für die Festlegungen und Umsetzung des Risikomanagements innerhalb des Qualitätsmanagementsystems. Sie pflegen die zukünftige EUDAMED Datenbank. Sie stehen im ständigen Kontakt zu Fachkreisen und Kunden im In- und Ausland.
Sales Manager (Neurovascular Therapeutics)
Expertise: Institutional Healthcare
Experience: 3 years
Business Expansion:Identify and pursue opportunities to grow the market presence of products, such as coils, stent retrievers, flow diverters, and similar devices, within hospitals, clinics, and healthcare providers.Product Expertise and Demonstrations:Develop a thorough understanding of neurovascular therapeutics devices in the portfolio. Conduct engaging and informative demonstrations to healthcare professionals, including neurosurgeons and interventional radiologists, highlighting product benefits and clinical applications.Technical Guidance and Training:Deliver comprehensive technical support and education to ensure clinicians are proficient and confident in using the devices. Serve as a trusted resource for healthcare providers during procedures involving the company's products.Market Insights and Strategy:Stay updated on advancements, competitive activity, and trends within the neuro field. Collaborate with key opinion leaders to gather insights and refine sales strategies based on emerging technologies and techniques.Client Engagement and Support:Build and maintain strong relationships with neuro & interventional specialists and hospital purchasing teams. Proactively address their needs, resolve product-related queries, and ensure high satisfaction levels.Sales Strategy and Performance:Develop and implement targeted sales plans, aiming to achieve and exceed goals within the neurointerventional segment. Monitor progress, provide accurate forecasts, and report on results.Regulatory Compliance and Documentation:Ensure all activities, including product demonstrations and promotional efforts, adhere to relevant regulatory standards and company policies, maintaining complete and accurate documentation as required.
Director, Medical Devices
Location: Montréal
Branche: Medical devices
Expertise: Production & Manufacturing
Experience: 5 years
Manage and provide leadership to Medical Device Product Development and engineering teams. Collaborate with cross-functional teams involved in Medical Device Development, including Quality, Supply Chain, Manufacturing, and Marketing. Mitigate and manage Medical Device Program risks by establishing and executing contingency plans. Lead and implement customer-centric medical device design programs. Work closely with Key Opinion Leaders (KOLs) and participate in clinical experience programs. Hire and lead the medical devices engineering team. Provide capital and human resource recommendations to support the execution of the Company's Product Development plan. Act as a Subject Matter Expert, ensuring compliant and robust medical device development and design history files. Lead the transition from development to commercial launch for medical devices. Facilitate the closure of the development gap between drug and device. Work collaboratively with Product Marketing & Business Development personnel to define the scope and requirements of potential development projects and product requirements throughout the life cycle of medical device products. Oversee Electrical Safety and EMC testing of Medical Devices as applicable. Lead the establishment and management of the engineering and design review board for medical device changes. Review proposed design changes and manufacturing process changes for Medical Devices. Manage the creation and maintenance of design history files and related risk management files. Approve Corrective and Preventive Actions (CAPAs) and investigations.
What do clinical project managers do?
Clinical project managers are invaluable to clinical research and project management. They ensure the successful execution of ongoing clinical trials and projects that help bring the latest medicines and clinical innovations timely and safely to the market. Sometimes the role is referred to as clinical project coordinator or clinical trial project manager.
The role of a clinical project manager
In this career, clinical project managers need to apply their creativity and technical skills to oversee and troubleshoot a range of clinical research-related problems. They are responsible for managing the operational aspects of clinical trials, ensuring compliance with regulations and protocols, and maintaining the smooth running of clinical projects. Clinical project managers work closely with cross-functional teams, including researchers, clinicians, regulatory representatives, project sponsors, and others, to effectively execute projects.
Clinical project manager tasks
Clinical project managers are involved in various tasks, including project planning and coordination, budget management, resource allocation, risk assessment and mitigation, timeline management, and quality control. They use project management software and tools to track metrics and progress, monitor milestones, and communicate updates to stakeholders. Additionally, they collaborate with internal and external teams to develop and implement strategies for successful project outcomes.
Where do Clinical project managers work?
Given the importance of conducting clinical trials and research studies in the healthcare industry, clinical project managers can readily find job opportunities in pharmaceutical companies, contract research organizations (CROs), academic institutions, and healthcare organizations.
Common responsibilities of a Clinical project manager
- Facilitating effective communication among all clinical project stakeholders;
- Managing project documentation, including study protocols, informed consent forms, case report forms, and regulatory submissions;
- Conducting regular project status meetings, providing updates on project progress, and addressing any issues or concerns;
- Ensuring data integrity and quality control throughout the project, including monitoring and auditing activities;
- Overseeing clinical site selection, initiation, monitoring, and closeout activities for clinical trials;
- Collaborating with vendors and external service providers to ensure timely delivery of project requirements;
Adhering to project timelines, budgets, and quality standards, and ensuring project deliverables meet customer
expectations;
- Ensuring the safety and well-being of participants involved in clinical trials;
- Traveling to clinical trial sites as necessary to provide on-site support and monitoring.
Qualifications for Clinical project managers
Clinical project managers should have at least a Bachelor's degree in a relevant field, such as life sciences, healthcare administration, or clinical research. Advanced degrees or certifications in project management, clinical research, or a related discipline are also advantageous.
Additional supporting skills and experience include:
- 3-5 years of experience in clinical research, project management, or a related field;
- Solid understanding of clinical trial processes, regulations, and industry standards;
- Excellent organizational, planning, and coordination skills;
- Proficiency in project management software and tools;
- Strong verbal and written communication skills;
- Knowledge of data management and analysis techniques;
- Familiarity with regulatory guidelines, such as ICH-GCP and FDA regulations;
- Experience in managing clinical trials across multiple phases and therapeutic areas;
- Strong problem-solving and decision-making abilities;
- Knowledge of medical terminology and clinical research terminology.
