Job Details

Are you an experienced Sr. Study Specialist, Global Study Operations with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr. Study Specialist, Global Study Operations to work at their company in San Rafael, CA.

Position Summary: The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study-related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and managing more challenging or complex vendors, sites, and regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate proficient knowledge and experience in the following competencies:

Primary Responsibilities/Accountabilities:

• The client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
• We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options.
• The client aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative therapeutics, advancing the standard of care, and providing personalized support and services globally. The Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
• Develop study-specific documentation, as delegated by the Study Manager
• Contribute to the oversight of country and site feasibility assessment and site selection.
• Oversight of CRO for IRB/EC-related submission/approval activities
• Oversight of essential documents for study life-cycle management
• Develop/Oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely
• Oversight of Clinical Trial Insurance
• Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as
• Oversee and manage study entry and updates to ClinicalTrials.gov
• Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
• Process documents for signature in DocuSign
• Contribute to Global Study Operations risks identification and mitigation.
• Provide support and administrative assistance with internal and external meetings
• End-to-end study operational understanding to support across start-up, maintenance, and close-out activities. (in a fast-paced, complex clinical trial environment)
• Proficient understanding of clinical trial lifecycle milestones, critical path dependencies, and inspection-readiness expectations.
• Ability to independently work in complex operational workstreams with minimal oversight, Systems & Platforms

Qualifications:

• BA/BS or higher in nursing, life, or health sciences is preferred. Industry or relevant experience in lieu
• of education is considered.
• Experience in a biotechnology or pharmaceutical company, oversight of external vendors, including
• SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging, etc.
• TMF/eTMF systems (quality, completeness, and inspection readiness)
• EDC experience (operational interfaces, timelines, and dependencies)
• IRT/IXRS and eCOA/ePRO operational support as applicable
• Tracking vendor milestones, site activities, and KPIs
• Familiar with TEAMS and SharePoint Platform
• Strong discipline in system accuracy, reconciliation, and data integrity.

Preferred:

• Agility and Proactivity
• Leadership
• Communication and Collaboration
• Study Management and Execution
• Compliance and Quality
• Drug Development and Study Design
• Product and Therapeutic Area Knowledge