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- 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 systems including, but not limited to: study team lists, tracking of project specific training requirements, system access management, 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 and maintaining audit readiness. - 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, 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 prepares study metrics reports. - Maintains vendor trackers. - Assists with coordination and compilation of Investigator Site File (ISF) template and 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. • 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 Country Regulations (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). Effective oral and written communication skills • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems • Ability to successfully complete CRG training program • Self-motivated, positive attitude and good interpersonal skills
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