Location: Europe, Middle East & Africa-Bulgaria-Sofia-Sofia
Closing Date: 27 Mar 17
Type: Full Time
Salary (£): On Application
The basic purpose of the Project Assistant is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager. ...
The basic purpose of the Project Assistant is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.
Responsibilities include, but are not limited to;
Reviews regulatory documents for proper content
Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools
Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departments
Assists with the identification of potential investigators and development/distribution of initial protocol packets
Creates meeting agendas and minutes
Coordinates team conference calls and distribution of meeting minutes
Education and Experience:
University Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
Knowledge, Skills and Abilities:
Excellent communication and interpersonal skills
Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
Flexibility to reprioritize workload to meet changing project timelines
Responsible for adhering to Good Clinical Practices, country specific regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
Excellent English and grammar skills
Fluency in English and in the country's native language
Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)
Ability to mentor and train new Project Assistants as needed
PPD is an Equal Opportunity Employer
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