Clinical Trial Specialist

Job Description

HI-Bio, Inc., a Biogen company, is seeking a Clinical Trial Specialist (CTS) or Senior CTS to assist in the execution of Clinical Trials. The successful candidate will be able to support the conduct of clinical trials with minimal guidance/supervision while ensuring alignment with GCP and HI-Bio’s SOPs. The Specialist provides a high level of administration, coordination and organizational support to the Clinical Study Lead and team members from all functions involved in assigned study(ies). The role requires an ability to manage multiple priorities consecutively and priorities consecutively and sequentially and meeting quality standards for accuracy, attention to detail and timelines. As part of a growing clinical development operations team, the Specialist will help define various aspects of clinical trials to ensure timely completion, efficient protocols, budget alignment, and compliance with ICH/GCP Guidelines.

The role reports to the Head of Development Operations. Level will be commensurate with experience.

KEY RESPONSIBILITIES:

• Overall global tracking of study deliverables with escalation of key issues/trends.
• Support and/or manage protocol related site/supplier activities.
• Assist and/or manage in the design, format, review and content of study guides, worksheets, quick reference cards and other materials/documents used to support the study.
• Contribute to protocol review and amendment management, including informed consent initiation and updates.
• Attend, contribute and potentially lead supplier meetings; work with suppliers to resolve issues, and foster process improvements.
• Monitor progress of studies, help identify study related trends/issues and work with Clinical Trial Managers (CTM) to implement corrective actions when necessary.
• Submission of documents to TMF and assist with TMF reconciliation as needed.
• Oversee study start-up activity tracking with CTM oversight
• Assist tracking study milestones in tools and dashboards.
• Point of contact (as delegated) for study related issues.
• Contribute to the development of recruitment strategies and materials; assist with external recruitment activities and supplier management.
• Work with sample management to coordinate shipment and analysis of sample needs; lead reconciliation efforts.
• Support and contribute to Inspection Readiness processes.
• May participate in cross-functional study management activities and process improvement initiatives.
• Lead Site Management Oversight tasks to ensure CRO activities are being completed per the Monitoring Plan.
• Contribute to protocol review, content and ICF development.
• Some travel may be required (<30%).

Qualifications

• Combination of degree and relevant Biopharma related experience within a pharmaceutical, biotech environment in a Clinical Operations function/role.
  • Bachelor’s degree and 3 years of direct related experience
  • OR Associates degree and 5 years of …