Clinical Development Operations Manager
hace 17 horas
We are seeking an experienced Clinical Site Manager to join our team at Icon Strategic Solutions. As a Senior Clinical Site Manager, you will be responsible for the planning, initiation, coordination, and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements.
The ideal candidate will have a minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry with a preference towards individuals who have experience in site engagement or an investigator-facing role. You will also have a strong understanding of ICH/GCP Guidelines, excellent verbal and written communication skills, and ability to operate effectively within an international and rapidly changing environment.
Responsibilities:- Plan, initiate, coordinate, and manage all monitoring and monitoring-related activities
- Supervise all site-related activities to ensure compliance with SOPs, GCP, and regulatory requirements
- Engage, evaluate, and develop high-quality investigative sites to support clinical development programs
- Collaborate with internal and external stakeholders, including clinical sites, investigators, and third-party vendors
In addition, you will work closely with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at site. You will also be responsible for ensuring appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
Requirements:- B.S., M.S. degree in a life science/biological related field preferred
- At least four years of experience in monitoring of trials in clinical development environment, preferably in phase 2-4
- A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator-facing role
- A demonstrated working knowledge of ICH/GCP Guidelines
- Strong facilitation skills
- Good collaborator
- Excellent verbal and written communication
- Ability to operate effectively within an international and rapidly changing environment
- Ability to supervise monitoring and related activities in a clinical trial
This is a hybrid position 30% Monitoring 70% Site Engagement. The successful candidate will be able to provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. They will also be able to conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.
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