Trial Administration Associate II

September 20

Apply Now

Receive Emails with Similar Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• 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 all allocated tasks are performed on time, within budget and to a high quality standard. • Escalates in cases of variances (over burn / under burn). • 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 issuer 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 Kickoff and Project Launch meetings and takes notes, supports initial study set-up.

Requirements

• 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 close out. • Good English language and grammar skills and proficient local languages skills (if required). • Effective oral and written communications skills with the ability to communicate effectively with project team members. • 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.