Trial management Specialist III

Work Schedule

Environmental Conditions

Job Description

Manages all clinical operational and quality aspects of allocated studies in compliance

with ICH GCP. Takes ownership for achieving the final clinical deliverable within the contractual time period specified within PPD development's contract with the customer. Manages CRF collection and query resolution process and assists as needed. Develops clinical tools, e.g. monitoring plan, monitoring guidelines in conjunction with data quality plan. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Communicates with study sites regarding issues such as protocol, patient participation, CRF completion and other study-related issues.