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 Supplies Project Associate (w/m/d)
Location: Mannheim
Branche: Life Sciences
Expertise: Production & Manufacturing
Experience: 1 years
Unterstützung der Clinical Supplies Project Manager (CSPM) bei der Bereitstellung klinischer Prüfmuster Zentraler Ansprechpartner für die CSPM-Gruppe für standardisierte Tätigkeiten in globalen klinischen Studien (Phase 1 bis 4) Erstellung von Aufträgen zur Verpackung und Etikettierung von klinischen Prüfmustern im Warenbewirtschaftungssystem Initiierung von Zusatzaktivitäten im Zusammenhang mit der Bereitstellung klinischer Prüfmuster Unterstützung bei Laufzeitverlängerungen von klinischen Prüfmustern und Um-/Überarbeitung bei Bedarf Kommunikation mit relevanten Schnittstellen bei Unklarheiten oder Änderungen von Zeitlinien Mitwirkung an der Entwicklung neuer Konzepte und Strategien zur Bereitstellung von klinischen Prüfmustern Teilnahme an lokalen und globalen Projektteams, Präsentation von Konzepten Mitarbeit bei der Erstellung und Überarbeitung von GMP- und GCP-relevanten SOPs
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.
Clinical Application Manager (Neuromonitoring)
Expertise: Institutional Healthcare
Experience: 3 years
Role OverviewWe are looking for a Clinical Application Manager to join our team, supporting a group of Scientists and driving the adoption of intraoperative neuromonitoring services in the market.The Clinical Application Manager will oversee daily operations of Scientists within a designated geographical region, focusing on team development, strengthening relationships with surgeons and hospitals, and exploring new business opportunities. This includes providing education and training, ensuring smooth execution of services, and managing regional and international activities as needed.Primary Responsibilities Supervise and support the operational and clinical activities of Scientists in the region. Build and nurture relationships with key stakeholders, including surgeons, anesthetists, and hospital administrators, to promote neuromonitoring services. Oversee workforce planning, training, and education to ensure team competency and professional growth. Collaborate with the Clinical Supervisor to develop strategies that align with organizational goals and support market expansion. Represent the team and organization in regional and international forums or meetings as required.Key Duties Apply advanced neuromonitoring techniques such as somatosensory evoked potentials, motor evoked potentials, EEG, EMG, and cranial nerve monitoring to provide real-time insights during surgeries. Troubleshoot technical issues to ensure seamless operation of equipment during procedures. Communicate monitoring strategies and findings effectively with surgeons and anesthetists. Maintain detailed documentation and prepare reports to support clinical and legal requirements. Manage equipment maintenance, including calibration and repair, and ensure adherence to safety and infection control standards.Skills and Qualifications Comprehensive understanding of neuromonitoring, neuroanatomy, and related fields. Proven leadership experience with a track record of supporting and managing teams. Strong analytical, interpersonal, and communication skills. Familiarity with market trends, resource management, and business development is advantageous. Bachelor’s degree in biomedical science, medical science, or related disciplines; advanced education in business or marketing is preferred. Minimum 4 years of experience in neuromonitoring with demonstrated expertise in intraoperative monitoring.
Health Care Assistant
Location: Doha
Branche: Conventional Energy
Expertise: Planning & Testing
Experience: 5 years
Focal point to daily check clinical areas, changing linen and ensuring there are adequate medical and stationary supplies.Escort and chaperone patients during clinical consultations and around Company Healthcare Services centre’s as requested.Assists with the lifting of immobile patients, i.e., from bed to chair and in and out of the ambulance.Assist within Primary Health Care clinics and with Chronic Disease Management, i.e. record height, weight, blood pressure, blood sugar peak/flow and urinalysis.Responsible for ordering laundry supplies and consumables, filing receipts and preparing monthly laundry statistics.Maintain medical supplies by ensuring that adequate stocks are available and maintain adequate functioning of medical equipment in nursing sections.Responsible for unpacking medical supplies, equipment and gas cylinders and checking for any signs of damage.Perform administrative tasks such as photocopying reports, documents and medical records as required.Transport patient files around the clinic maintaining patient confidentiality.Transport pathological samples around the clinic and between medical facilities as required.Maintain accurate manual and computerized patient records.Prepares clinical waste for safe storage and transportation in adhering to Company infection control policies in disposing of clinical waste, sharps, and body fluids safely and appropriately.Uses own judgments in First Aid and emergency situations and understand when to call for help!
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
Senior Scientist
Location: Richmond Hill
Branche: Medical devices
Expertise: Research & Development
Experience: 5 years
Drives the execution of technical development plans spanning preclinical animal studies through process validation to support IDE and PMA submission by leveraging expertise of Prollenium's Technical Subject Matter Experts (SME) and external Contract Manufacturing Organization (CMOs) Initiator of new projects for the R&D team for the purposes of commercialization to consistently sustain Prollenium's product pipeline Supervise project related scientific/technical activities and contribute to strategic decision by reviewing and evaluating data, interpreting results and drawing relevant conclusions Ensures technical readiness by designing, reviewing, and approving the animal study protocols for commencing preclinical studies in support of IDE submission Providing technical expertise by authoring drug and medical device IDE and PMA modular components covering product background, device description, preclinical testing, product biocompatibility, manufacturing process and product testing and characterization Partnering with Quality/Regulatory and Analytical Technical experts to prepare Technical Files and Design Dossiers in line with the different market requirements (Canada, US, Europe, Rest of the World) Assisting the Global Chief Scientific Officer in the evaluation key technologies of biotech companies and analyzing their technological capabilities for the purposes of Merger & Acquisition (M&A) activities Assisting the Global Chief Scientific Officer in evaluating budgetary proposals from Contract Manufacturing Organizations (CMOs) to determine the optimum budget for product characterization and biocompatibility studies Being a key member of the R&D, Regulatory and Clinical bi-weekly team meeting in the preparation of IDE and PMA submissions Communicating current scientific findings to the Global Chief Scientific Officer through peer-review journals, ISO standards and clinical trials in order to assist in Prollenium's product development pipeline Other duties as assigned
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.
Senior Director - Business Development
Location: Shanghai
Branche: Life Sciences
Expertise: Marketing & Sales
Experience: 5 years
Conduct due diligence, data analysis, and feasibility assessments on new business opportunities, providing reference for the company's senior management decision-making. Responsible for global License-in/out, co-development via business meeting, contract negotiation, track project process to secure the identification of the most attractive partnering opportunities and facilitate the achievement of project cooperation. Oversee the management of global/domestic partners, coordinate internal and external resources to provide prompt feedback and address partner needs. Proactively monitor the external business environment and maintain a knowledge base of licensing transactions and other company activities to adjust work priorities and strategy promptly.
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.
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.
