Senior Global Trial Specialist

Duties

• Contribute to the operational execution of clinical research studies from protocol development to final clinical study report.
• Ensure deliverables are on-time, within budget, and comply with applicable regulations and standard operation procedures.
• Edit and submit protocols and other required research documentation.
• Support clinical research study start-up, maintenance, and closure activities.
• Provide operational input and facilitate operational processes.
• Prepare, manipulate, and manage extensive databases.
• Verify the accuracy and validity of data entered in databases, correcting any errors.
• Perform descriptive and multivariate statistical analyses of data, using computer software.
• Participate, set-up agendas, and capture meeting minutes in study team meetings for assigned protocols.
• Track nonclinical supplies and expenses such as site payment processing.

Requirements

• A Bachelor’s degree or foreign equivalent in Healthcare, Nursing, or a related field, and five (5) years of progressive post-baccalaureate related work experience.
• Five (5) years of experience in the following skills (which may be gained concurrently): Creation and Maintenance of Study Related Mail Groups, Study Share Points, Transfer of Obligations, Enrollment Trackers, Study Contact List, Financial Disclosure Forms, Subject Alert Cards, Study newsletters, Global Study Team Meeting Minutes, Global Vendor Site List /Vendor Management (Mitigating vendor challenges to adopt the GVSL); and Management of study related meetings including Global Study Team Meetings, Investigator Meetings, Data Monitoring Committee Meetings, Clinical Safety Review Meetings, Study Steering Committee Meetings.
• Two (2) years of experience in the following skills (which may be gained concurrently): Using Clinical Trial Management Systems (CTMS) including Study Creation and Set Up, Milestones Review/Updates, Data Quality Dashboard Reports, Study Team Updates, Study Closure Activities, Managing integration of safety vigilance systems (CelAlert/Study investigator Platform); Using Clinical Trial Master File (TMF) systems including Creation of Core Study Documents and Plans which includes Vendor Trial Oversight Plans (VTOP), Trial/Project Management Plan, Conducting Quarterly TMF reviews, Creation and Management of Study Specific TMF Master List, TMF Plans, Communication Plan and Expected Document List, Inspection Preparation, TMF Archival Management, Responses to Audit Findings/ CAPA; Designing and reporting clinical trials involving human participants in compliance with the International Conference on Harmonisation's Guideline for Good Clinical Practice (ICH/GCP); and CRO oversight and considering the partnership level agreement for each study to assure compliance with the protocol and Standard Operational Procedures.