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 Supply Project Manager (w/m/d)
Location: Mannheim
Branche: Life Sciences
Expertise: Planning & Testing
Experience: 2 years
Als Project Manager sind Sie für die Koordination und das Management verantwortlich. Hierzu zählen die Planung und Verwaltung sowie die Überwachung. Darüber hinaus entwerfen Sie anhand von Studienprotokollen logistische Konzepte gemäß globaler Vorschriften. Sie identifizieren und verfolgen Projektzeitpläne, Ressourcenanforderungen und Budgetprognosen. In Ihrer Rolle arbeiten Sie mir verschiedenen Abteilungen zusammen. Hierzu gehören Statistiker, Quality Assurance sowie Materialmanagement. Abschließend unterstützen Sie bei der Lösung von Lieferproblemen und stellen die Einhaltung von Richtlinien sicher.
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.
Clinical and Medical Affairs Manager
Location: Richmond Hill
Branche: Life Sciences
Expertise: Research & Development
Experience: 3 years
The Clinical and Medical Affairs Manager will be responsible for ensuring compliance with regulations (SOPs, GCPs, FDA, Health Canada), managing clinical trials, and evaluating investigational sites in North America. Additionally, maintain the Trial Master File, collaborate with vendors for medical writing and data management, secure IRB approvals, and manage study budgets. The position also supports business development through relationship-building with clinicians and investigators and participates in medical affairs activities such as training sessions, continuing medical education events, and advisory boards. Ensure full compliance with all appropriate regulations: SOPs, GCPs, FDA, and Health Canada regulations. Assist in the planning, management, and execution of clinical trials. Help identify and evaluate investigational sites in North America. In collaboration with external vendors, assist in building, organizing, and maintaining the Trial Master File throughout the study. Collaborate with vendors for Medical Writing, Medical Monitoring, Data Management, and Statistics, as required. Help with planning and management of study budgets. Secure IRB study approvals and help with sites' IRB submissions and approvals. Support business development efforts by building and maintaining relationships with industry professionals, clinicians, and investigators. Collaborate and support North American medical affairs activities, such as training sessions, advisory boards, CME events, presentations, etc. Occasional travel may be required.
Technical Sales Specialist
Location: Greater Toronto Area
Branche: Medical devices
Expertise: Marketing & Sales
Experience: 3 years
Bachelor's degree in life sciences 2-3 years of sales experience 3+ years of clinical microbiology experience Excellent communication and interpersonal skills for relationship building Ability to explain technical concepts to diverse audiences Self-motivated with strong organizational and time management skills Strategic mindset for market analysis and competitor research Ability to travel across Canada and internationally as needed French language skills are an asset but not required
Pharmacovigilance Associate
Location: Ontario or Quebec
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Responsibilities Data Entry of Individual Case Safety Reports (ICSRs) to the pharmacovigilance (PV) safety databases as per corporate and local requirements and timelines. Ensure that ICSRs for marketed products and medical devices subject to expedited reporting according to Canadian regulations are submitted to Health Canada within prescribed timelines. Monitor and support the preparation of written follow up requests to ensure timelines prescribed by local/global and corporate requirements are met. Perform reconciliations of the company's third party vendors programs, licensed partners as well as inter-departmental teams, as per corporate requirements and monitor key performance indicators. Provide support for the compliance monitoring of Individual Case Safety Reports (ICSRs) and generating metrics on case handling. Manage the external vendor training records including the launching of annual refresher training. Process Canada Vigilance queries and Access to Information requests/results. Support the analysis of reports in PV databases. Respond to queries and requests from internal and external stakeholders. Support the company's Project Leaders in compiling information for the LPSMF on a regular basis. Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), working instructions and job aids. Participate in the maintenance of the PV paper and electronic filing and archiving system according to corporate and Canadian requirements. Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV. Provide overall support to PV team activities.
Bilingual Medical Information Specialist
Location: Greater Toronto Area
Branche: Pharmaceuticals
Expertise: Communications & Distribution
Experience: 2 years
Support MICC within assigned therapeutic Ensure quality of the information provided to our customers by supporting and monitoring MICC external supplier who is providing just in time evidence- based information and scientific expertise on the company's products. Provide guidance to MICC external supplier in a timely fashion on day-to-day requests within assigned therapeutic areas. This includes scientific response documents for verbal and written frequently asked questions, as well as response to ad hoc enquiries. Handle escalated Provide support to MICC external supplier for primary intake of adverse events and product complaints, in collaboration with Pharmacovigilance and Quality Assurance teams. Perform quality control of MICC external Provide regular feedback/training to MICC external supplier to optimize Medical Information services. Develop and maintain Canadian product scientific response documents: Contribute to the development, review and update of scientific response documents such as FAQs/Q&As, letters and technical sheets for use in verbal and written responses. Contribute to literature Maintain strong relations with Canadian and Global Medical Information teams to optimize sharing of product information. Ensure Medical Information materials are compliant with Canadian and Global Medical Information good scientific practices. Contribute to product launch readiness within the assigned therapeutic Contribute to optimization of Global Medical Information Assess value of scientific response documents for access through Medical Information self-serve web portal. Collaborate with internal Participate in the development of specific technical/medical responses or analysis to specific situations such as product discontinuation, media attention, crisis situations and responses to Health Canada or other organizations within the assigned therapeutic areas. Analyze and share customer insights with commercial and field teams to meet customer needs. Deliver training on Medical Information services and processes for commercial, field teams and patient support program suppliers.
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.
