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.
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.
Analytical Chemist
Location: Hamilton
Branche: Pharmaceuticals
Expertise: Research & Development
Experience: 4 years
We have a current opportunity for a Analytical Chemist on a permanent basis. The position will be based in Hamilton. For further information about this position please apply.
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.
