Job Summary:

The Clinical Trial Specialist (CTS) is responsible for assisting with study management of assigned projects in accordance with SOPs, Good Clinical Practice (GCP), International Conference of Harmonization (ICH) guidelines and local regulations. Study management activities may include maintenance of information databases and trial tracking reports, coordination of clinical trial documentation and general support to ensure the successful and timely execution of clinical activities and deliverables.

Key Accountabilities:

• Develop, organize and maintain tracking systems and tools across multiple programs to support efficient execution, oversight and compliance of a clinical study from start-up to closeout
• Coordinate and lead the development, review and maintenance of study management tools, monitoring tools, study manuals and training materials and presentations
• Schedule meetings, coordinate and distribute meeting agendas, minutes, and follow-up action items for study teams.
• Establish, manage and oversee study files and shared spaces to ensure accuracy, accessibility and compliance
• Manage documentation of study training to ensure compliance
• Manage study sample and supply accountability and develop collaborative relationships with vendor teams.
• Partner with the study management team to Lead or manage specific projects as appropriate.
• Serve as a key point of contact for study team members, facilitating effective communication and proactive resolution of study challenges
• Conduct and oversee quality control reviews of trial-level documents ensuring compliance with study procedures and regulatory requirements
• Ensure timely, complete and compliant archiving of the TMF in accordance with study and regulatory
• Actively participate in and contributes to company, departmental and project team meetings including Investigator Meetings, providing input and updates as appropriate
• Familiar with and assist in maintaining clinical invoice tracking and other budget databases for projects, generate periodic reports on status of payments and resolve payment inquiries from investigator sites

Requirements:

• 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, effectively collaborating with study teams and site, CRO staff and vendors
• Strong organization and interpersonal skills
• Proficiency using eTMF systems to support inspection readiness
• Strong attention to detail and consistency in document quality, compliance and completeness
• Ability to prioritize and manage multiple tasks and competing deadlines in a fast-paced study environment
• Proactively identify, investigate and resolve routine issues while effectively managing deadlines
• High sense of urgency and strong time management skills, independently managing workloads across multiple studies
• Proficient with MS Office Suite (Excel, Word, PowerPoint) with ability to independently develop reports and presentations

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