Assist with study management of assigned projects in accordance with SOPs, GCP, ICH guidelines and local regulations
Develop, organize and maintain tracking systems and tools across multiple programs
Coordinate and lead the development, review and maintenance of study management tools
Schedule meetings, coordinate and distribute meeting agendas, minutes, and follow-up action items
Establish, manage and oversee study files and shared spaces
Manage documentation of study training to ensure compliance
Develop collaborative relationships with vendor teams
Conduct and oversee quality control reviews of trial-level documents
Ensure timely, complete and compliant archiving of the TMF

BS/BA degree or degree in healthcare scientific field required
Minimum of 2+ years of experience in clinical operations within a biopharmaceutical company or 3+ years experience in a CRO environment with increasing responsibilities for independent study support
Strong knowledge of drug development and clinical operations processes
Applies working knowledge of clinical trial processes and regulatory requirements to independently support study execution in compliance with ICH/GCP and Code of Federal Regulations
Excellent written and verbal communication skills
Strong organization and interpersonal skills
Proficiency using eTMF systems
Strong attention to detail and consistency in document quality, compliance and completeness
Ability to prioritize and manage multiple tasks and competing deadlines
Proficient with MS Office Suite (Excel, Word, PowerPoint)

Clinical Trial Specialist

Key skills