Study Start Up Specialist I

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