FSP Site Navigator I (BeijingShanghai)

Job Overview:

Primary contact with investigative sites during study maintenance and -when assigned- site startup activities with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation guidance and practice in the assigned countries with the support from senior staff.

Summary of Responsibilities:

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 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 (Minimum Required):

• 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

Physical Demands/Work Environment:

• General Office Environment.

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