Job Description

Purpose:

Provides administrative and technical support to the Project Team. Coordinates and facilitates project activities and may serve as a study lead acting as a cross-functional liason for the project team. Acts as a buddy during onboarding phase and provides training to new staff as needed. Supports departmental and cross-functional initiatives for process improvements/enhancements.

Essential Functions:

According to the specific role (Central or Local), 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. Proactively communicates any risks to project leads and line

manager as appropriate.

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. Ensures (e)TMF is up to date by following

file review schedules and documents findings in appropriate system.

Provides system support (i.e. GoBalto & eTMF).Supports RBM activities.Performs administrative tasks on assigned trials including but not limited to:

timely processing of documentssent to Client (e)TMF as assigned, performing

(e)TMF 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 of related meeting minutes.

Reviews and tracks local regulatory documents.Transmits documents to client and centralized IRB/IEC.Analyzes and reconciles study metrics and findings reports. Assists with

clarification and resolution of findings related to site documentation.

Maintains vendor trackers.Assists with coordination, compilation and distribution of Investigator Site File

(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.

Assists with study-specific translation materials and translation QC upon request.May attend Kick off meeting and take notes when required.

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.Bachelor ´s degree preferred.Experienced finance profile.Knowledge, Skills and Abilities: Ability to work in a team or independently as requiredStrong organizational skills and attention to detail, with proven ability to handle multiple tasks

efficiently and effectively

Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiencyStrong customer focusDemonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet

changing project timelines

Demonstrated ability to attain and maintain a good working knowledge of applicable Country

Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

Excellent English language and grammar skills and proficient local language skills as neededGood presentation skillsExcellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain

knowledge and master all clinical trial database systems

Ability to successfully complete PPD clinical training programSelf-motivated, positive attitude with effective strong interpersonal skills