Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
Role 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 manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:
Core Competencies:
- Agility and Proactivity
- Leadership
- Communication and Collaboration
Technical Competencies:
- Study Management and Execution
- Compliance and Quality
- Drug Development and Study Design
- Product and Therapeutic Area Knowledge
Responsibilities include but are not limited to:
- 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)
- Oversee and man 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 mitigations.
- 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 Proficient use of core clinical systems, including:
- 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