Project Assistant - L
Pharmaceutical Product Development, LLC.
Capital District, Colombia
hace 22 días

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
  • Qualifications

    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
  • Organization

  • Clinical Management
  • Latin America-Colombia-Capital District-Bogota
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