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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Quality Assurance & Compliance Manager
Location: Calgary
Branche: Pharmaceuticals
Expertise: Quality Management
Experience: 4 years
Maintain and continuously improve the Quality Management System (QMS) Develop and implement an annual Quality Plan and perform internal quality audits Conduct external vendor qualifications and investigative site audits Deliver GCP and regulatory training to internal teams and external partners Lead or support regulatory inspections and sponsor audits, including readiness, hosting, and follow-up Manage the CAPA lifecycle and analyze trends in quality findings Review SOP deviations, ensure audit follow-through, and maintain compliance documentation Collaborate closely with Clinical Operations, QA Specialists, and IT to uphold quality across functional teams Track and report quality performance metrics and KPIs to leadership Promote a proactive quality culture while addressing ongoing operational needs
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.
Pharmacovigilance Specialist
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Responsibilities Collaborate in maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines, participating in other Pharmacovigilance (PV) processes and ensuring appropriate contacts with internal and external stakeholders. Collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance (GPV). Document and update case information into the PV safety database as as per Good Documentation Practices (GDPs). Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local PV procedures. Respond to queries and requests from internal and external stakeholders. Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines. Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), work instructions and job aids. Provide support in the Periodic Safety Report activities in accordance with Canadian regulations and corporate procedures. Support activities involving product launch, risk management plans, studies, safety queries, handling product alerts, and review of product monographs and protocols. Provide support in the maintenance of Canadian product list and reporting rules for PV database configuration. Support local literature review activities including oversight of the review performed by global vendors, maintaining lists of journals and products, and handling literature-related queries. Provide training and on-going support as well as perform quality assurance and quality control for work delegated to the global PV vendors (CPOC, i.e. Country PV Operating Center) and addressing issues. Provide support for Signal Detection and Local Safety Surveillance activities in accordance with regulatory and corporate requirements. Maintain current knowledge of all relevant local Pharmacovigilance regulations for Sanofi marketed products. Educate internal and external stakeholders on the implications of existing PV regulations and guidance documents along with local and global procedures and policies. Provide support in monitoring compliance with Canadian and foreign case management activities and implement corrective and preventative actions involving the PV team. Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV. Provide overall support to the PV team activities.
Medical Affairs Operations Coordinator
Location: Markham
Branche: Life Sciences
Expertise: Communications & Distribution
Experience: 0 years
Responsibilities Manage and co-ordinate daily medical operations, including round table-discussions, advisory board meetings, videos, medical booths, disease awareness campaigns etc. Status tracking and reporting to Affiliate management Localize Global MSL materials using Veeva Vault system Manage Teams calendars and meetings and support with travels Support the approval of tier-1, less complex promotional materials Liaise with third party vendors for development of materials and resources Liaise with KOLs and healthcare experts in specific projects Competent in technology and systems including Veeva Vault, SAP, Veeva CRM Comfortable in using authorized AI tools to optimize the workflow and timelines Occasionally, Liaise between teams (Marketing, medical, clinical operations etc) to optimize collaboration and project delivery for Medical Affairs projects Assist in developing and managing budgets from third party providers including medical education agencies, AV companies etc. Identify opportunities to improve operational efficiency and cost-effectiveness Ensure adherence to healthcare regulations, licensing requirements and internal policies Ensure all medical activities are aligned with IMC as well as internal SOPs Provides operational support as needed for the Medical team
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.
