Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summarized 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 and Other Job Information:

• 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 documents sent 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.

• Bachelor's degree preferred.
• 4-6 years of previous experience that provides the knowledge, skills, and abilities to perform the job

• 4-5 Years of experience and strong knowledge of Clinical Trials, experience with eTMF (preferably Veeva, other experiences can be considered), CTMS, Essential Documents, ICH GCP Guidelines.
• Must have very good Business communication skills
• 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