Sr. Associate, Clinical Data Operations

About the Job:

The Senior Clinical Data Operations Associate in Data Management performs a range of activities in support of functional processes and contributes to the continual improvement of department processes, knowledge management and training initiatives. This position performs operational and tactical support for Bio Pharma, FMI and Academic Collaborator clinical trials. The Senior Clinical Data Operations Associate ensures accurate sample tracking, receipt of accurate information about samples from partners, Query management and resolution, data entry for complex studies, accurate and timely data reporting, and coordination of sample returns.

The role works closely with internal and external teams within FMI.

• Provide data reporting and study operational support.
• Set up folder structure for all new studies in study repository/Trial Master File (TMF).
• Monitor archiving of study documentation in study repository/TMF as study is ongoing and at study closure.
• Track sample processing and deliver study-specific sample status reports (SST) to Clinical Program Leads, identifying samples that have passed, are on hold, and failures.
• Monitor query process and query partners/collaborators to obtain missing information.
• Complete Study Intake information in CRM/Clinical Trial Management System.
• Manage sample return and destruction process for all Partners/Collaborators.
• Train Associate team members on relevant procedures, act as a resource for less experienced team members.
• Upload, enter, and maintain new study sample data in FMI’s internal data management system.
• Perform advanced quality control and ensure accuracy of all data provided to pharmaceutical partners.
• Ensure comprehensive review and processing of confidential and time-sensitive information.
• Act as a liaison between Clinical Data Operations team and Technology.
• Ensure quality standards for all procedures are met including compliance with HIPAA, GDP, and GCP.
• Proactively identify and raise issues related to data or sample integrity, provide recommendations for resolutions as needed.
• Coordinate and communicate all relevant study activities to ensure timely delivery of partner milestones.
• Track deviations and non-conformance reports related to non-compliance with functional procedures.
• Manage content and maintain department intranet/SharePoint site with landing page for tools, templates, training material and Study Team folders.
• Assist with developing training sessions on best practices, regulatory requirements and topics to facilitate continuous improvement and adherence to standards and regulations.
• Collaborate cross-functionally with sub-teams including Bioinformatics, Data Management, Alliance Management, Clinical Operations, and Technology, for:
  • Releasing and holding reports as needed;
  • Report template and IXRS transfers;
  • Daily study specific reporting schedule;
  • Customer Relationship Management;
  • WLM, BI and PRA.
• Other duties as assigned.
• Comply with FMI's attendance policies

• Bachelor’s degree or in scientific field or equivalent combination of education, training and experience
• 1+ years of professional work experience in the science or health industry

• 4+ years of professional work experience in the science or health industry
• Experience in process improvement and implementation
• Demonstrated evidence of success working in a cross-functional environment
• Familiarity with oncology, molecular biology, genetics and/or bioinformatics
• Knowledge of Good Clinical Practice (GCP)
• Proficient in MS Office suite
• Successful history of performing complex tasks under deadline pressure
• Ability to:
  • Perform assignments with minimal supervision
  • Work well under pressure while maintaining a professional…