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 Development Scientist
Location: Eindhoven
Branche: Medical devices
Expertise: Research & Development
Experience: 0 years
You'll be involved throughout the clinical development lifecycle: Conduct benefit-risk assessments and support risk management throughout the product lifecycle. Collect, appraise, and analyze clinical data to support product safety and performance. Write and maintain high-quality documentation such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) reports. Collaborate with internal stakeholders (regulatory affairs, statisticians, risk management, etc.) and external parties (consultants, authorities) to deliver strong clinical evidence. Support clinical investigations and product submissions in the US, EU, and other global markets. Lead clinical risk assessments from early development through to market launch. Review and optimize procedures and workflows within the Clinical Development team.
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.
Director of Regulatory
Location: Canada
Branche: Life Sciences
Expertise: Research & Development
Experience: 3 years
Responsible for preparing client proposals and generating new business, including leading presentations to potential RA clients, and participating in multifunctional presentations Prioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines and client expectations; anticipate and resolve emerging issues Responsible for development and implementation of RA activities including assessments, strategies, submissions and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US etc.) and at least basic knowledge outside of core area Maintain target billables by obtaining new business Creates opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications and webinars Leads client and agency interface, with responsibility for strengthening relationships and growing the business. Responsible for the quality of deliverables, by ensuring compliance with the company and client review and approval processes; identifies and implements opportunities for process improvement Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities Analyze data, the regulatory environment and business objectives to make and implement recommendations, using judgement to identify innovative solutions while managing uncertainty. Lead and advise clients and cross-functional teams on agency interactions Leads decision-making and conflict resolution surrounding regulatory issues within cross-functional teams Proactively identifies, shares and interprets regulatory intelligence Manage multiple simultaneous projects to ensure that they are on budget, meet timelines and client expectations. Engages in continuous learning activities in order to provide effective consulting services and be a sought-after resource. Develop and manage 0-2 regulatory direct reports at Manager level or below, as assigned including but not limited to assignment delegation, time and budget management, skill and knowledge development
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.
