FSP SSU I (Shanghai)

Roles and Responsibilities:

Support the day-to-day operations of assigned activities within SSU to ensure completionperestablished goals andobjectivesin compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to supporttimelycompletion of both drug and non-drug program goals andobjectives

Generate and provideaccurateand up-to-date project status and financial information (whereappropriate)within relevant tracking systems/tools

Proactivelyidentifyand escalate issues that arise related to support SSU deliverables

Effectively execute against assigned activities within SSU

Support implementation of standards for global SSU team

This may include:

Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager includingCDA and questionnaire collection ICF negotiations IRB/EC submissions IMPReleaseand other site activation requirements

Implementation of the SSU Strategy for assigned region during the study start up period

Building relationships with internal counterparts and site staff to support successful site activation strategies

Projecting site activation timelines and appropriately escalating when things get off track

Adhering to process and tools designed to the support of the SSU team with day-to-day activities

Leading the preparation of study level essential document templates

Aiding in the preparation of content for Regulatory submissions

Handling ICF negotiations andfacilitatingany required escalations

Preparation and submission of IMP Release Packages

Maintainingaccurateandtimelyinformation in relevant clinical systems

Responsible forcomplying withregulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff.

Qualifications:

Required Qualifications:

BS/BA degree orAssociatesdegree with 2 years of experience in the health care field or direct clinical trial related experience.

Must have knowledge of clinical trial conduct

General knowledge of drug development and ICH/GCP guidelines

Requires proven project management skills

Must have excellent interpersonalwrittenand verbal communication skills administrativeskillsand computer ability.

Fluent in English.

Minimal (0-5%) travelrequired

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