About the Job

The 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 BioPharma, FMI and Academic Collaborator clinical trials. The 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.

The Clinical Data Operations Associate in Data Management performs operational and tactical support and ensures quality control and delivery of patient data to FMI’s Pharmaceutical and Academic research partners. The incumbent is responsible for accurate sample tracking and handling and timely data reporting and data entry that impacts the successful implementation and ongoing execution of FMI clinical partnerships. This role works closely with internal teams at FMI and external partner teams.

Key Responsibilities

• Provide ongoing study operational support.

• Setup 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 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/or have failed.

• 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.

• Submit final report for Pathology approval.

• Upload, enter, and maintain study sample data in FMI’s internal data management and reporting systems.

• Handle query management and resolution.

• Perform quality control and ensure accuracy of all data provided to our Academic and Pharmaceutical partners.

• Ensure quality standards for data reporting are met, including compliance with HIPAA, GDP, and GCP.

• Proactively identify and raise issues related to data integrity and process improvements; provide recommendations for resolutions as needed.

• Coordinate and communicate all relevant study activities to ensure timely delivery of partner milestones.

• Collaborate cross-functionally with sub-teams including Bioinformatics, Data Management, Clinical Operations, Lab Operations and Technology for:
  • Releasing reports and holding reports;
  • Report template and IXRS (interactive response system) transfers;
  • Daily study-specific reporting workflows to ensure deliverables meet TAT (Turn Around Time);
  • Partner Relationship Management;
  • Internal Tech Solutions with WLM (Work List Manager), BI (Business Intelligence), PRA (Pharma Reporting Application, Partner Portal and CRM (Customer Relationship Management).

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor's Degree in a health or science field

Preferred Qualifications

• 1+ year(s) of professional work experience in the science or health industry

• Familiarity with oncology, clinical research, molecular biology, genetics and/or bioinformatics

• Successful history of performing tasks under deadline pressure

• Demonstrated strong attention to detail

• Demonstrated ability to work with a cross-functional team

• Ability to perform assignments with minimal supervision and in a timely manner

• Excellent verbal and written communication skills

• Strong organizational, administrative, and analytical skills

• Strong prioritization skills

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to values held at FMI: Patients, Innovation, Collaboration, and Passion

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