Full-Time Principal Country & Site Activation Manager
- Lead study level country and site start-up activities by understanding the study objectives and assist/deputise for the CSA STOM Lead in the development of the global plan for country and site activation
- May act as the STOM squad lead dependent on experience
- Oversees day to day delivery of all aspects of global country site activation in the projects assigned.
- Ensures that each project has a country and site activation plan and that country activations are planned in a single wave to maximise start up performance across all countries selected for a trial
- Meets the study timelines and expectations and complies with SOPs, reporting norms, appropriate regulations, and quality standards
- Input into project update and status calls, and other communications
- Utilize project management skills to optimize performance and collaboration to ensure successful study outcomes
- Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyses information and develops innovative solutions to challenges
- Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
- Contribute to process improvement efforts both within the department and in cooperation with other departments
- Transition oversight accountabilities to the SDL at the end of the start-up phase.
- Bachelor’s degree – Business, Science or Math, Study Management, Clinical Operations or related discipline.
- Significant clinical operations experience preferably across multiple TAs and phases of development in Rx and Vx.
- Experience of being a senior Study Start Up Lead/SSU Team Leader or have been involved with leading the delivery of clinical studies
- Experience analyzing data to optimize clinical trial delivery and to create various scenarios to support the operational design of a trial.
How to ApplyI am looking for someone who has the broader knowledge and significant experience in clinical operations preferably across multiple TAs, understanding of relevant country regulations, GCP and ICH Guidelines for clinical research etc. If you think you are the one please click on the link below to apply or email me your resume at firstname.lastname@example.org https://gsk.wd5.myworkdayjobs.com/ro-RO/GSKCareers/job/Canada---Ontario---Mississauga/Principal-Country---Site-Activation-Manager_368332
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