Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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 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 qualification

Technical positions may require a certificate

Previous 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 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 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