Work Schedule

Environmental Conditions

Job Description

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.

Day to day:

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/clienst, 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.

Qualifications:

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.

Bachelor's degree preferred.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at

least 4 years).

In some cases an equivalency, consisting of a combination of appropriate education, training

and/or directly related experience, will be considered sufficient for an individual to meet the

requirements of the role.

Knowledge, Skills and Abilities:

 Ability to work in a team or independently as required

 Strong 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 efficiency

 Strong customer focus

 Demonstrated 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 nonclinical/clinical aspects of project implementation, execution and closeout

 Excellent English language and grammar skills and proficient local language skills as needed

 Good presentation skills

 Excellent 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 program

 Self-motivated, positive attitude with effective strong interpersonal skills

Management Role:

No management responsibility

Working Conditions and Environment:

 Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to

electrical office equipment.

 Occasional drives to site locations. Potential Occasional travel required.

Physical Requirements:

 Frequently stationary for 4-6 hours per day.

 Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements

of the fingers, hands, and wrists.

 Occasional mobility required.

 Occasional crouching, stooping, bending and twisting of upper body and neck.

 Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop

computer with a maximum lift of 15-20 lbs.

 Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

 Ability to communicate information and ideas so others will understand; with the ability to listen to

and understand information and ideas presented through spoken words and sentences.

 May interact with others, relating and gathering sensitive information. Interaction includes diverse

groups.

 Works with guidance or reliance on oral or written instructions from management. May require

periods of intense concentration.

 Performs a wide range of variable tasks as dictated by variable demands and changing conditions

with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

 Regular and consistent attendance.