**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office**Essential Functions and Other Job Information**:- Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.- Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.- Coordinates, under guidance, with internal functional departments to ensurevarious site start-up activities are aligned with submissions activities andmutually agreed upon timelines; ensures alignment of submission process forsites and study are aligned to the critical path for site activation.- Achieves PPD's target cycle times for site.- May have contact with investigators for submission related activities.- May act as a key-contact at country level for either Ethical or Regulatorysubmission-related activities.- Works with the start-up CRA(s) to prepare the regulatory compliance reviewpackages, as applicable.- Assists in developing country specific Patient Information Sheet/InformedConsent form documents.- Assists with grant budgets(s) and payment schedules negotiations with sites.- Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timelymanner- Ensures the local country study files and filing processes are prepared, set upand maintained as per PPD WPDs or applicable client SOPs.- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
**Qualifications**:**Education and Experience**:Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
**Working Conditions and Environment**:- Work is performed in an office/ laboratory and/or a clinical environment.- Exposure to biological fluids with potential exposure to infectious organisms.- Exposure to electrical office equipment.- Personal protective equipment required such as protective eyewear, garments and gloves.