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**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office- Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.- Ensures allocated tasks are performed on time, within budget and to a high quality standard.
Escalates in cases of variances (overburn/underburn).- Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including, but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.- Provides system (i.E.
CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents, maintaining audit readiness and communicating the non-compliance to the study team.- Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews and coordinating for issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.- Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes.- Exports and reconciles study metrics reports.
Maintains vendor trackers.- Proactively assists with coordination and compilation of Investigator Site File (ISF) template, pharmacy binder, with instruction from the Clinical Team Manager.- When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.Education and Experience:High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).Knowledge, Skills and Abilities:- Ability to work in a team or independently as required- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency- Strong customer focus- Good time management skills.
Flexibility to reprioritize workload to meet changing project timelines- Demonstrated ability to attain and maintain a good working knowledge of applicable CountryRegulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout- Good English language and grammar skills and proficient local language skills (if required)