**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 integral 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 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.

📌 Ctry Approval Spec (México)
🏢 Thermo Fisher Scientific
📍 México