Senior Clinical Project Coordinator
hace 4 semanas
We are seeking a highly skilled Clinical Study Manager to join our team at Pharmiweb.
The ideal candidate will have a strong background in clinical research and project management, with experience in leading cross-functional teams and managing multiple projects simultaneously.
The Clinical Study Manager will be responsible for the overall management of clinical studies, including planning, execution, and monitoring. This will involve working closely with internal stakeholders, such as study directors and project managers, as well as external partners, such as contract research organizations (CROs) and investigative sites.
The successful candidate will have excellent communication and interpersonal skills, with the ability to build strong relationships with colleagues and external partners. They will also have a strong understanding of clinical development processes and regulations, including ICH/GCP.
Key responsibilities will include:
- Leading the preparation of delegated study documents, including informed consent forms and clinical study agreements
- Maintaining and facilitating interactions with internal and external functions, including CROs and other external service providers
- Conducting internal and external meetings, including investigator and monitor meetings
- Ensuring the supply of investigational product and study materials
- Proactively identifying and mitigating risks and issues
- Ensuring that all study documents are complete and verified for quality in the trial master file
- Supporting global study directors and/or GSAD with budget management and overall project management
The ideal candidate will have a university degree in a relevant field, such as medical or biological sciences, and at least 3 years of experience in clinical research or a related field. They will also have excellent knowledge of international guidelines, including ICH/GCP, and excellent communication and relationship building skills.
If you are a motivated and experienced clinical study manager looking for a new challenge, please apply for this exciting opportunity.
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