Trial Activation Approval Specialist II
Share
Job Location:
Monthly Salary:
Posted on:
15-10-2025
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
- Prepares review and coordinates submissions (MoH EC applications if e.g. gene therapy approvals safety dossiers import license) in alignment with global submission strategy.
- Provides strategy advice (MoH &/or EC) to clients.
- Develops and implements local submission strategy. Provides expertise and coordination oversight for projects in collaboration with relevant internal departments.
- Serves as primary contact for investigators and with the local authorities (in collaboration with the local regulatory manager for sophisticated issues) to ensure submissions are managed in a timely manner.
- Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators and with the country regulatory authorities to ensure submissions are managed in a timely manner.
- Acts as a key-contact at country level for all submission-related activities.
- Participates as the need arises in Submission Team Meetings Review Meetings and Project Team meetings.
- Coordinates 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 PPDs target cycle times for site activations.
- Prepares the regulatory compliance review packages as applicable.
- Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
- Develops country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
- Supports the coordination of feasibility activities as required in accordance with agreed timelines.
- Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
- Oversees country study files and ensures that they meet PPD WPDs or client SOPs.
- Maintains knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
- Advises/mentos other SIA individuals assigned to support projects of responsibility as appropriate
- Proactively identifies issues or anomalies in the regulatory process of a study resolves or escalates as appropriate.
Required Experience:
IC
Key Skills
- Business
- Marketing
- Key Decision Makers
- Active Directory
- Customer Service
- Performance Evaluations
- Federal Regulations
- Communications
- Account Management
- Project Management
- Minimum Data Set
- Budget management
- Powerpoint
- Direct Reports
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
