广州招聘

Essential Functions：

According to the specific role (Central or Local), coordinates, oversees and completes administrative functions on assigned trials activities detailed on the task matrix, including but not limited to the following: Reviews and tracks local regulatory documents, handles wet-ink documents as required per study/sponsor specifications. May transmit documents to client and centralized IRB/IEC TMF/Project file set-up (Central and Internal files). Submits documents to TMF. Analyzes and reconciles project documents, metrics and findings reports within specified timelines. Processes local payments (translations, EC/IEC, other local vendors, etc.) Performs mass mailings and communication as needed. Maintains vendor trackers. Provides accesses to company, client and vendor systems. Assists with coordination and compilation of Investigator Site File (ISF) and Pharmacy binder materials. Distributes (ISF) and Pharmacy binders and other paper supplies to sites. Performs file review at any required level (Central, Internal, Country and/or Investigator) and records findings in CTMS as applicable. Assists with study-specific translation materials and translation QC upon request. Assists with clarification and resolution of findings related to site documentation. Maintains assigned data points within CTMS according to the established conventions within specified times, including entry of findings Assists on project management ad-hoc activities, produces reports, assists on study plans edition. Coordinates team conference calls, completes and distributes meeting minutes from internal/client/vendor meetings as applicable Involvement on Go-Balto use during study Start up. Involvement on CTMS triage activities to assist on RBM strategy. Provides ad hoc support as needed.

Qualifications:

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred.

Previous general administrative experience preferrably in clinical research administration that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

？ Ability to work in a team or independently, as required

？ Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively

？ Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

？ Strong customer focus

？ Flexibility to prioritize workload to meet changing project timelines

？ Demonstrated ability to attain and maintain a good working knowledge of ICH GCP, applicable regulations and PPD/Client procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout

？ Good English language and grammar skills are needed while proficiency is mandatory for Centralized role

？ Good computer skills, proficient in MS Office, ability to obtain knowledge and master all clinical trial database systems. Leverage modern technology when applicable

？ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

？ Skills to work under constant pressure to meet project/client deliverables and timelines

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit ************.