The Senior Study Specialist supports and, at times, leads operational activities for clinical studies, with a focus on site oversight, vendor management, and study execution. Working closely with the Study Manager or Program Lead, this role helps ensure participant safety, data integrity, study quality, timelines, and budget adherence. The position requires a high level of independence, experience managing complex vendors, sites, and regions, and the ability to effectively handle escalations and key investigator relationships.
Key Responsibilities
- Support and develop study-specific documentation as delegated by study leadership.
- Contribute to feasibility assessments, site selection, and site start-up activities.
- Provide oversight of CRO activities, including IRB/EC submissions and approvals.
- Manage essential documents across the study lifecycle, including oversight of the Trial Master File (TMF).
- Develop, oversee, and deliver site and investigator training materials.
- Present at investigator meetings when assigned.
- Ensure accurate and timely updates to clinical trial registries (e.g., ClinicalTrials.gov).
- Facilitate and track screening authorization documentation where applicable.
- Coordinate document execution using electronic signature systems.
- Oversee clinical trial insurance documentation.
- Represent Global Study Operations in cross-functional, vendor, and study execution meetings; document and distribute meeting minutes as needed.
- Contribute to identification and mitigation of operational risks.
- Provide administrative and logistical support for internal and external meetings.
Core Competencies
- Agility and proactive problem-solving
- Leadership and ownership of assigned activities
- Strong communication and cross-functional collaboration
Technical Competencies
- Clinical study management and execution
- Compliance and quality oversight
- Understanding of drug development and study design
- Product and therapeutic area knowledge
Education & Experience
- Bachelor’s degree or higher in nursing, life sciences, or health sciences preferred (relevant industry experience may be considered in lieu of formal education).
- Experience in biotechnology or pharmaceutical clinical operations.
- Demonstrated experience overseeing external vendors, including contracts/SOWs, budgets, purchase orders, and invoice management (e.g., CROs, central labs, imaging vendors).