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.
Ready to take the next step?
Apply now for a job as a Clinical Project Manager!
Mitarbeiter Qualitätssicherung / Clinical QA (w/m/d)
Branche: Pharmaceuticals
Expertise: Quality Management
Experience: 0 years
GMP-gerechte Bearbeitung von Produktreklamationen für klinische Prüfpräparate. Eigenständige Durchführung von Untersuchungen und zeitgerechte Koordination von Laboruntersuchungen. Erstellung von Untersuchungsberichten und Unterstützung bei der Ursachenermittlung bei Abweichungen. Festlegung geeigneter CAPA-Maßnahmen (korrigierend oder präventiv) und pharmazeutische Beurteilung der Auswirkungen auf Sicherheit und Qualität der Arzneimittel. Administrative Unterstützung bei der Freigabe klinischer Prüfpräparate. Erstellung von Dokumenten für Import/Export und klinische Prüfanträge. Bearbeitung von Änderungen der Herstellungs- und Importerlaubnis sowie benannter Personen. Erstellung von QP-Declarations, Pedigrees und BSE/TSE-Statements für die Einreichung klinischer Studien.
IT System Specialist - Clinical Supply Management (CSM) (w/m/d)
Location: Mannheim
Branche: Life Sciences
Expertise: IT & Shared Services
Experience: 2 years
System- und Prozessoptimierung: Analyse, Definition und Implementierung neuer globaler und lokaler Prozesse zur Steigerung von Effizienz und Qualität. Incident- & Problemmanagement: Eigenständige Bearbeitung komplexer IT-Vorfälle - von der Ursachenanalyse bis zur Lösung - sowie Support globaler Systemanwender. Schnittstellen- und Datenmanagement: Verwaltung von Stammdaten, Aufbau und Betreuung von IT-Schnittstellen sowie Unterstützung bei Systemupgrades und -änderungen. Reporting & Dokumentation: Erhebung und Visualisierung von KPIs, Pflege der Systemdokumentation, SOPs und Freigaben im Rahmen des System-Lebenszyklus. System- und Anwenderschulung: Erstellung, Pflege und Durchführung von Schulungen und Trainingsmaterialien für CSM-IT-Systeme weltweit.
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
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.
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.
