Hybrid Ctry Approval Assoc Ctry Approval Assoc with verification

Work ScheduleOtherEnvironmental ConditionsOfficeTrial Activation Approval Specialist IPrepares, reviews and coordinates, under guidance and local EC submissions inalignment 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 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 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 qualificationPrevious 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.