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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Fachreferent IT-Systeme Clinical Supply (w/m/d)
Branche: Pharmaceuticals
Expertise: IT & Shared Services
Experience: 0 years
Verantwortung für die Erstellung und Pflege von Schulungsunterlagen zu den CSM-IT-Systemen sowie eigenständige Durchführung von Systemschulungen für neue Mitarbeitende Abbildung und Integration von Prozessen externer Partner in den CSM-IT-Systemen, einschließlich Stammdatenmanagement und Berücksichtigung der Auswirkungen auf relevante Systemfunktionen Bearbeitung von Anfragen und Problemlösungen im Zusammenhang mit der Funktionalität der CSM-IT-Systeme sowie eigenständige Analyse und Behebung komplexer Störungen - von der Ursachenanalyse bis zur finalen Lösung Selbstständige Definition neuer globaler Prozesse innerhalb des CSM-Bereichs unter Berücksichtigung der Systemfunktionalitäten sowie Erstellung von User Requirement Specifications (URS) Ausarbeitung und Umsetzung von Optimierungsvorschlägen zur Verbesserung bereichsübergreifender Arbeitsprozesse mit Fokus auf Effizienzsteigerung und Kostenoptimierung Vorbereitung und Implementierung von IT-Schnittstellen zu CSM-IT-Systemen sowie Definition der jeweiligen Systemanforderungen Erhebung, Aufbereitung und Visualisierung von Kennzahlen (KPIs) und Statistiken; Entwicklung von IT-Lösungen für neue lokale Prozesse und Prozessoptimierungen - von der Konzeptphase über Tests bis zur Implementierung Übernahme von Aufgaben im System Lifecycle Management, einschließlich Dokumentation, UAT-Freigaben, Systemzugangsfreigaben sowie Koordination von Upgrades und Systemänderungen in Zusammenarbeit mit Fachbereichen und IT Koordination und Aktualisierung globaler SOPs, Arbeitsanweisungen und Schulungsunterlagen im Bereich Clinical Supply Management in Bezug auf die IT-Systeme der Clinical Supply Systems Business Excellence Group Kommunikation mit globalen Anwendern der CSM-IT-Systeme bei komplexen Problemstellungen, Unterstützung bei CAPAs sowie Evaluierung neuer Prozesse, Systemupgrades und Änderungen
Clinical Marketing Manager
Location: Mississauga
Branche: Medical devices
Expertise: Marketing & Sales
Experience: 4 years
Responsibilities * Lead lifecycle planning for diabetes care products (pre-launch, launch, postlaunch). * Partner with cross-functional teams to develop and refine clinical messaging and product positioning. * Translate clinical and market insights into actionable marketing strategy and launch support. * Build relationships with healthcare professionals, leading clinicians, medical societies, and other clinical stakeholders. * Gather feedback from the medical community and create insight loops to guide marketing direction. * Support medical education initiatives, speaker programs, and clinical advocacy development. * Create and review scientific materials (presentations, slide decks, speaker content) to ensure accuracy and compliance. * Monitor trends and competitive activity, and collaborate with Medical Affairs, Regulatory, and Global teams on strategic initiatives
Medical Science Liaison
Location: Toronto
Branche: Pharmaceuticals
Expertise: Planning & Testing
Experience: 3 years
Responsibilities Develop and maintain mutually beneficial, peer-to-peer relationships with the scientific community The MSL spends a significant amount of their time on customer-facing activities to develop relationships with external customers including scientific experts, researchers, educators and clinical investigators. The MSL serves as a major medical representative of Lilly for these health care professionals, providing deep and advanced disease state and product information as well as facilitating the work of the scientific expert when it aligns with Lilly's mission. An important aspect of the MSL's work is to connect thought leaders and scientific experts with other Lilly resources (e.g., Discovery, Real World Evidence Scientists, Clinical Research Physicians and Global/Canadian External Research & Development). The MSL is considered a reliable, trusted resource of accurate, up-to-date medical and scientific knowledge requested and desired by their customers. They will respond in a timely way to personal or electronic inquiries with any available information which may include reprints or posters, medical letters, literature citations, access to internal and external experts, slides and other teaching-related material. Continually enhance scientific knowledge The MSL is required to maintain technical expertise within therapeutic areas to engage in scientific discussions with scientific experts. The MSL is expected to engage in continuous learning within the therapeutic areas they represent. They will attend appropriate scientific meetings, conduct routine literature searches, and will be expected to communicate regularly with other MSLs so the entire group benefits from relevant learning. Support the affiliate medical business objectives and cross functional partners The MSL is responsible for interfacing the scientific expert and Lilly resources/internal business partners such as Clinical Research Physicians, Medical Information Associates, Medical Education, Corporate Affairs, and Marketing as requested by the expert. The MSL gathers and reports clinical insights and unanswered questions received from scientific experts to the medical and other cross-functional teams. The MSL job entails not only scientific and customer expertise, but also requires the ability to understand and effectively utilize approved resources, and administrative, procedural and legal requirements to address customer needs and support internal Lilly business.
Regional Sales Manager
Location: Richmond Hill
Branche: Medical devices
Expertise: Marketing & Sales
Experience: 0 years
Responsibilities * Own and develop a U.S. sales territory focused on hospital and acute care environments * Drive sales of capital equipment across Operating Room, ICU, and Acute Care settings * Build and maintain relationships with hospital leadership, clinicians, surgeons, nursing teams, and materials management * Identify, prospect, and secure new business while growing existing hospital accounts * Deliver consultative sales presentations and support clinical workflow planning * Manage the full sales cycle from initial outreach through post-sale follow-up * Maintain accurate sales forecasts, CRM documentation, and activity reporting * Travel throughout the U.S. to support territory growth and customer engagement
Data Analyst / IT-Systemexperte (m/w/d)
Location: Mannheim
Branche: Life Sciences
Expertise: IT & Shared Services
Experience: 0 years
Erstellung und Pflege von Schulungsunterlagen für CSM-IT-Systeme sowie eigenständige Durchführung von Trainings für neue Mitarbeitende Abbildung von Partnerprozessen in CSM-IT-Systemen, inklusive Stammdatenpflege und Berücksichtigung der Auswirkungen auf alle relevanten Systemfunktionen Bearbeitung von Anfragen und Störungen im Zusammenhang mit der Systemfunktionalität sowie eigenständige Analyse und Lösung komplexer technischer Probleme (Root Cause Analysis bis zur Behebung) Definition neuer globaler Prozesse im Bereich Clinical Supply Management unter Berücksichtigung der Systemanforderungen und Erstellung von User Requirement Specifications Entwicklung von Vorschlägen zur Optimierung bereichsübergreifender Arbeitsabläufe zur Steigerung von Effizienz und Kostenstruktur Planung und Implementierung von IT-Schnittstellen zu CSM-Systemen sowie Erarbeitung entsprechender Systemanforderungen Erhebung, Auswertung und Visualisierung von Daten, Statistiken und KPIs; Entwicklung und Umsetzung von IT-Lösungen für neue oder optimierte Prozesse - von der Idee über das Testing bis zur Implementierung Verantwortung für System-Lifecycle-Aktivitäten, einschließlich Dokumentation, UAT-Freigaben, Zugriffsfreigaben sowie Koordination von Upgrades und Systemänderungen in Abstimmung mit IT und Fachbereichen Koordination und Pflege globaler SOPs, Arbeitsanweisungen und Trainingsmaterialien im Bereich Clinical Supply Management Kommunikation mit globalen Systemanwendern zu komplexen Problemstellungen, CAPA-Maßnahmen, Prozessänderungen sowie System-Upgrades und -Erweiterungen
Medical Science Liaison
Branche: Pharmaceuticals
Expertise: Planning & Testing
Experience: 3 years
Responsibilities Establish and maintain relationships with key thought leaders, regional advocates, healthcare organizations, professional societies and government contacts. Provides accurate and up-to-date scientific information that supports the company's product and disease strategies Builds and maintains rapport with medical professionals and their clinic staff Represent Allergan at national and regional scientific meetings and professional congresses. Collaborates with Medical Advisor in the development and coordination of Allergan sponsored symposia and speaker's bureau Identify and develop advocates for participating in Allergan sponsored clinical trials, scientific symposium and speaker bureau and advisory boards. Follow-up on unsolicited investigator-initiated research proposals and publication opportunities. Assist in training sales and business personnel. Develops territory routing that effectively supports the medical information needs of the assigned geography Maintains effective budgetary control of medical expenses Completes administrative responsibilities, as required, on time Carries out responsibilities in accordance with the organizations, federal and provincial laws and regulations Knowledge Health Canada (HC), Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP), PAAB, Rx&D, PMPRB and other regulatory requirements. Public speaking, scientific story telling and presentation methods and techniques. Pharmacology and pharmaceutical principles, practices and their application. Principles of mathematical and statistical analysis in clinical studies
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: 1 years
Responsibilities 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
CMC Regulatory Consultant
Location: Hamilton
Branche: Pharmaceuticals
Expertise: Planning & Testing
Experience: 4 years
Responsibilities Serve as the CMC regulatory point of contact for global Health Authority Questions (e.g. FDA, EMA, MHRA, PDMA, other regions as applicable). Train on the company's ERV/Veeva Vault system and manage HAQ responses within the ERV system Coordinate HAQ response development across internal technical teams. Track HAQs, response timelines, commitments, and dependencies to ensure on-time, high-quality submissions. Interpret and apply global/regional CMC regulatory guidelines and regulations. Review SME-drafted HAQ responses for regulatory appropriateness, clarity, consistency and alignment with regional CMC expectations. Extract and summarize scientific information from development reports and identify details required for regulatory submissions. Organize data to support the group's function with answering questions, information request from regulatory agencies such as the FDA, Health Canada or EMEA (including relevant country specific authorities). Advise SMEs on how to frame technical data and rationales to meet Health Authority expectations.
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.
