The Clinical Business & Systems (CB/S) Specialist supports the CB/S team. The key task areas for this position include support for the BioClinica Clinical Trial Management System (CTMS), support for the Clinical Trial Master File (CTMF) structure and filing process, maintaining the new hire checklists, handling logistics for the Clinical Development Lunch & Learn program.
• Support BioClinica CTMS system build and implementation process. Includes CTMS Administrator support, handling meeting and training logistics, coordinating or conducting quality checks of TrialWorks to BioClinica mapping, coordinating UAT activities, supporting training and training documentation.
• Support TrialWorks CTMS system administration tasks. Includes adding new or updating existing users, monitoring study investigator assessments, and generating regular reports.
• Support eTMF new vendor selection project. Includes activities for mapping the DIA reference model to Seattle Genetics CTMF, vendor evaluation status tracking (such as removed vendors or current candidates).
• Maintain CTMF files. Includes the controlled document check-out/check-in process, preparing for and assisting with QA document audits, creating project and study folders, assist with filing of Product level documents (such as records received from Medical Writing and IND Safety Letters), coordinating creation of study-specific CTMF Creation Forms, ensuring quality CTMF files in compliance with the Training Guide TG-001, monitoring space issues in the Controlled Document Storage Room (CDSR), handling document archive and retrieval from Iron Mountain, maintaining adequate supplies.
• Monitor CDSR access. Includes CDSR access training for new CTAs, ensuring access compliance with Training Guide TG-001.
• Maintain New Hire Checklists. Includes initiating the checklist, routing new user forms, printing orientation manuals, tracking close-out of checklists to completion.
• Coordinate Lunch & Learns. Includes scheduling, facility and IT arrangements, managing set-up and break-down, preparing recordings in Adobe Captivate and loading them in TrainingWire.
• Support Records Retention Biannual Clean-Up Day Activities. Includes logistics, scheduling, email reminders, and fielding questions.
• Coordinate Clinical Development surveys. Includes implementing requests, preparing and distributing results.
• Perform CB/S quality checks. Includes K: \Clinical Records and K: \Clinical Operations\Clinical Business file and folder review for naming convention and document retention policy compliance, employee and contractor training folder review, TrainingWire user profile or curriculum reviews.
• Maintain CB/S calendar. Includes creating meeting invites, scheduling group and individual recurring meetings.
• Prepare and maintain CB/S binders. Includes New Hire Manuals, Clinical Business monthly payment and dashboard report binders, Clinical Business financial study closure letter binder, CB/S SOP and Training Guide binders, CB and CS procedure manuals.
• Support Clinical Finance efforts. Includes scanning and saving invoices and check requests to the clinical drive.
• Support Clinical Contracts efforts. Includes the NDA Process and updating the contract and budget trackers.
• Support Weekly Document releases. Includes updating the Cross Reference Table, scanning & filing of signature approval forms.
• Additional tasks or projects as needed.
• Minimum two years college, BA or BS preferred.
• Strong administrative and communication skills
• Keen attention to detail
• Experience in biotechnology or clinical trials environment
• Good office software skills such as Microsoft Outlook, Word and Excel.
Seattle Genetics is an equal opportunity employer.