Job Description
Roles and 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:
Required Qualifications:
· 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.
· Fluent in English.
· Minimal (0-5%) travel required
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