**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local SSU services and coordination of these projects.
- May have contact with investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- 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 work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- May develop country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
- Entes and maintains trial status information relating to SSU activities onto PPD 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).
**Knowledge, Skills and Abilities**:
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and the ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations