Clin Ops Delivery Associate III

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 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 non-clinical/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