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 (m/w/d)
Location: Mannheim
Branche: Life Sciences
Expertise: Research & Development
Experience: 1 years
Sie unterstützen die Clinical Supplies Project Manager (CSPM) bei der Bereitstellung und Koordination von klinischen Prüfmustern für globale klinische Studien (Phase 1 bis 4). Sie fungieren als zentraler Ansprechpartner für standardisierte Tätigkeiten innerhalb der CSPM-Gruppe und unterstützen bei der Planung, Organisation und Koordination von Prüfmustern. Sie sind verantwortlich für die Erstellung von Aufträgen zur Verpackung und Etikettierung in einem Warenbewirtschaftungssystem und initiieren damit verbundene Zusatzaktivitäten. Sie assistieren den Projektmanagern bei der Laufzeitverlängerung und bei Bedarf der Um- oder Überarbeitung von klinischen Prüfmustern. Sie kommunizieren mit relevanten Schnittstellen wie dem Verpackungs- und Label-Team, TEG-Gruppe, QA, Warenlager und Versand bei Unklarheiten oder Änderungen von Zeitlinien. Sie arbeiten an der Erstellung und Überarbeitung von GMP- und GCP-relevanten SOPs und präsentieren Konzepte in lokalen und globalen Projektteams.
Scientist Biochemie (m/w/d)
Location: Mannheim
Branche: Life Sciences
Expertise: Research & Development
Experience: 1 years
Entwicklung, Validierung und Durchführung von bioanalytischen Methoden von Proteinwirkstoffen gemäß geltender Richtlinien und Standards Optimierung / Etablierung Labor-assoziierter Prozesse unter Einhaltung geltender Richtlinien Gewährleistung der Grundsätze der Guten Laborpraxis (GLP) sowie der Good Clinical Practice (GCP) Erstellung und Pflege einer GLP- bzw. richtlinienkonformen Dokumentation (SOPs, Prüfpläne, Berichte) Troubleshooting Assayentwicklung und Erarbeitung/Präsentation von Lösungsstrategien Automatisierung der analytischen Methoden auf Laborrobotern
Entwicklungsingenieur in der Medizintechnik (m/w/d)
Location: Würzburg
Branche: Life Sciences
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.
Medical Information Associate
Location: Toronto
Branche: Pharmaceuticals
Expertise: Communications & Distribution
Experience: 1 years
Medical information provision Provide medical information responses to unsolicited medical questions from internal business partners and external customers, through a variety of channels. Planning, researching and writing scientifically complex, high quality, balanced, scientifically based consistent and accurate medical information responses for customers in response to unsolicited questions from customers. Medical information materials creation and update Prepare materials for contact center and patient support programs Create medical information responses and/or localize global medical information responses to reflect Canadian regulations, labeling and resources. Subject Matter Expert for Medical Information Apply the medical information expertise and analytics to medical information communication plan including channel selection Engage scientific and clinical discussions by leveraging compound and disease knowledge and medical information-related knowledge including the relevant regulations Leadership Lead and/or facilitate transformation to maximize the value of medical information Share best practices about medical information-related activities with others Provide expert consultation and coach to others Additional responsibilities Power User of on-line databases, systems, customer relationship management (CRM) tools and authoring software. Review promotional, advertising and educational materials for scientific soundness and technical accuracy
Associate Director, Business Development
Location: Shanghai
Branche: Pharmaceuticals
Expertise: Research & Development
Experience: 5 years
Work closely with local Chinese drug development companies to build partnerships using DNA based clinical trial services for biomarker discovery and development. Manage new account onboarding activities including, lead generation, CRM data entry, due diligence and contracting while also supporting strategic account initiatives, identifying and making new connections. Develop strong, long-term relationships with key decision makers within accounts and develop in-depth knowledge of the customers' needs and provide appropriate solutions. Guide and educate potential partners, whether biomarker researchers, translational medicine scientists or clinical development teams and support BD Director with identifying new Companion Diagnostic opportunities as they arise from the clinical trial services and data produced by collaborations. Be well connected internally to address customer needs. Work across functions to solve problems, find solutions and deliver an outstanding customer experience. Interact with regularly include Research Operations, Alliance Management, Bioinformatics, Quality, Medical Affairs, Legal, and Finance. Partner and problem solve with people across the research, clinical and business groups, must be able to influence and shape opinions and help teams reach decisions and deliver on customers' needs.
Head of MSAT
Location: Shanghai
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 5 years
Responsible for TS team development and management. Responsible for implementing the manufacturing process in the plant. Act as the process acceptor into DS manufacturing from internal mAb and bioconjugation process development as well as drop-ins from other clinical facilities and customers. Participating in cross-functional teams as an expert tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals. Actively communicates, presents data, and collaborates with the customer via both face-to-face meeting and teleconferences. Contribute to the preparation of the validation master plan.
Medical Education Manager
Location: Toronto
Branche: Pharmaceuticals
Expertise: Research & Development
Experience: 2 years
Responsibilities Partnering with HCPs to gather feedback and insights on their learning needs to advise the Medical Education Strategy Plan. Collaborating with Thought Leaders, Faculty, and Speakers to develop educational content and as a result provide unbiased learning opportunities that meet HCP needs in both official languages Accountable for transforming HCP needs and strategy into the development of fair and balanced educational solutions across all therapeutic options aligned with principles of adult education and instructional design. Lead the development and ongoing execution of medical education tactical plans from strategic concept through implementation, execution, design, and deployment including budget and vendor management, leveraging their scientific and clinical therapeutic area knowledge and business acumen Collaborating with Brand team(s) to understand commercial strategy, Medical to incorporate the latest scientific data, Sales for logistical implementation of educational solutions and Compliance to ensure the highest ethical standards Providing an excellent learning experience that triggers practice change to optimize patient care
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.
