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 Research Officer (CRO)
Location: Haarlem
Branche: Life Sciences
Expertise: Research & Development
Experience: 2 years
Wat ga je doen? Leiden van klinische studies: Je bent als Clinical Study Team Leader (CSTL) verantwoordelijk voor het opzetten, coördineren en afronden van klinische studies. Dit omvat het formuleren van doelstellingen, opstellen van protocollen, beheren van budgetten en aansturen van het team. Kwaliteitsborging en compliance: Je zorgt dat elke studie voldoet aan wet- en regelgeving (GCP), interne richtlijnen en ethische standaarden. Ook borg je dat alle administratieve aspecten (zoals contracten en budgetten) correct worden afgehandeld. Samenwerking en communicatie: Je onderhoudt nauw contact met interne en externe stakeholders zoals projectleiders, Regulatory Affairs, Quality Assurance en andere betrokkenen. Je zorgt ervoor dat iedereen op de hoogte blijft van de voortgang van de studie. Monitoring & ondersteuning: Indien nodig neem je zelf monitoring- of datamanagementtaken op je, en ondersteun je andere CSTL's. Ook voer je kwaliteitscontroles uit op studiemateriaal en stuur je (junior) collega's en trainees aan.
Contract Associate Clinical Trial
Location: Zaventem
Branche: Pharmaceuticals
Expertise: Research & Development
Experience: 2 years
As a Clinical Contracts Associate, you will be responsible for: Adapting budget templates to local and site-specific requirements. Drafting, reviewing, and negotiating contracts, amendments, and work orders. Analyzing documents for corporate risk and proposing appropriate solutions. Negotiating with research sites in line with internal policies and applicable regulations. Coordinating with Legal and other internal stakeholders regarding contract terms such as confidentiality, liability, intellectual property, etc. Reviewing and approving translations in informed consent documents related to injury, privacy, and compensation.
Bioanalytiker (w/m/d)
Location: Mannheim
Branche: Pharmaceuticals
Expertise: Research & Development
Experience: 2 years
Eigenständige Planung und Durchführung von bioanalytischen Methodenentwicklungen und Validierungen - mit Fokus auf Ligandenbindungsassays zur Bestimmung von Wirkstoffkonzentrationen in verschiedenen Matrices (z. B. Serum) Optimierung und Etablierung laborassoziierter Prozesse unter Einhaltung geltender Richtlinien Sicherstellung der Grundsätze der Guten Laborpraxis (GLP) sowie der Good Clinical Practice (GCP) Erstellung und Pflege einer GLP- bzw. richtlinienkonformen Dokumentation (SOPs, Prüfpläne, Berichte) Troubleshooting bei der Assayentwicklung sowie Erarbeitung und Präsentation von Lösungsstrategien Automatisierung bioanalytischer Methoden auf Laborrobotern (z. B. Tecan, Hamilton)
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.
Territory Sales Representative
Location: Richmond Hill
Branche: Medical devices
Expertise: Marketing & Sales
Experience: 0 years
Managing a US territory with a focus on distribution and direct sales Reporting and working with a District Sales Manager Live product presentation to key decision makers in hospital that include: Nurse Managers, Clinical Engineers, Respiratory Therapists, Purchasing agents and Project Managers Grow and foster new relationships with key Architects, Designers and Equipment Planners within your region Work directly with local distributors Training, Recruiting and Managing of distribution channels in your region
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
Medical Sales Representative
Location: Quebec City
Branche: Life Sciences
Expertise: Marketing & Sales
Experience: 3 years
Develop sales and territory management plans in collaboration with the Sales Manager to mobilize the necessary resources to maximize market penetration. Build relationships with key medical representatives and conduct one-on-one or joint visits to build relationships with existing and potential clients; To present the products and therapeutic approaches and their benefits in order to create demand for the products. Install equipment for clinical trials of products, train hospital staff, and troubleshoot issues to promote product acceptance. Interact with the hospital's regulatory, compliance, and technical departments to remove any barriers to compliance, if any. Install the products and train and assist hospital staff to ensure customer satisfaction and correct use of the products. Provide training, troubleshooting, and post-sale complaint resolution to quickly identify customer issues, ensure proper equipment utilization, drive consumables sales, and ensure customer satisfaction. Attend trade shows and conventions to showcase products and explain their use in order to build relationships with distributors. Prepare management reports to inform management of the progress of the business plan, assess market conditions, identify competitor activities and demonstrate good territory management.
Records Management Coordinator
Location: Toronto
Branche: Pharmaceuticals
Expertise: Legal
Experience: 1 years
Secondary Principal RIM Steward Duties: Promote awareness and ensure compliance with Lilly's Global Records Management policies and procedures. Coordinate quarterly records clean-up activities, including logistics, communication, and reporting. Collaborate on project-specific archiving across various departments. Complete annual self-assessment for compliance and assist in implementing electronic records management processes. Liaise with Global RIM staff regarding updates to retention schedules and procedures. Ensure proper handling of records under litigation holds in collaboration with legal counsel. Assist in audit activities and ensure departmental RIM stewards are trained and assigned. Maintain and update the Canada Records Retention SharePoint site or equivalent collaboration space. Coordinate with external clinical study sites on document retention and disposition. Third-Party Storage - Records Archivist Responsibilities: Manage Iron Mountain account, ensuring accurate user access and up-to-date information. Oversee the indexing and description of archived documents, collaborating with department owners. Coordinate the annual destruction process in line with retention schedules. Assist in updating and organizing archived box information and compliance documentation. Prepare and submit monthly invoice-related files and participate in audits as required. Administrative Duties: Pull reports from internal repositories such as Veeva QualityDocs. Respond to Freedom of Information and Access to Information requests. Manage external filings related to corporate records and registrations. Undertake additional projects or tasks as assigned.
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.
