Senior Project Assistant (Start-up), Prague

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.





Currently, PPD is looking for a Project Assistant to join our team in Prague, Czech Republic





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:





Bachelor's 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 FDA Good Clinical Practices, FDA 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

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 (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.