Study Start Up Specialist

Summary of Responsibilities:

• Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in 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 support timely completion of both drug and non-drug program goals and objectives

• Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools

• Proactively identify and 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 including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and 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 and facilitating any required escalations

• Preparation and submission of IMP Release Packages

• Maintaining accurate and timely information in relevant clinical systems

• Responsible for complying with regulations 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 or Associates degree 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 interpersonal, written and verbal communication skills, administrative skills and computer ability.

• Advanced / Fluent in English.

• Minimal (0-5%) travel required

Please, submit your English resume

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