Job Description

Trial Activation Approval Specialist I

Essential Functions and Other Job Information:

Essential

Functions

• 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.