Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• 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 ensure
  various site start-up activities are aligned with submissions activities and
  mutually agreed upon timelines; ensures alignment of submission process for
  sites 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 Regulatory
  submission-related activities.
• Works with the start-up CRA(s) to prepare the regulatory compliance review
  packages, as applicable.
• Assists in developing country specific Patient Information Sheet/Informed
• Consent 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 timely
  manner
• Ensures the local country study files and filing processes are prepared, set up
  and 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 0 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.