Associate, Clinical Data Operations

Foundation Medicine

1d•Onsite

About The Position

The Clinical Data Operations Associate in Data Management performs a range of activities supporting functional processes and contributing to continual improvement of department processes, knowledge management, and training initiatives. The position provides operational and tactical support for BioPharma, FMI, and Academic Collaborator clinical trials. It helps ensure accurate sample tracking and partner-provided sample information, 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.

Requirements

Bachelor's degree in a health or science field.
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 reflect FMI’s values: Integrity, Courage, and Passion.

Nice To Haves

At least one year 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.

Responsibilities

Provide ongoing study operational support.
Set up folder structures for new studies in the study repository/Trial Master File (TMF).
Monitor the archiving of study documentation in the study repository/TMF during study conduct 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, or have failed.
Monitor the query process and query partners or collaborators to obtain missing information.
Complete Study Intake information in the CRM/Clinical Trial Management System.
Manage sample return and destruction processes for partners and collaborators.
Submit final reports for Pathology approval.
Upload, enter, and maintain study sample data in FMI’s internal data management and reporting systems.
Manage and resolve queries.
Perform quality control and ensure the accuracy of data provided to Academic and Pharmaceutical partners.
Ensure data reporting meets quality standards, including compliance with HIPAA, GDP, and GCP.
Identify and raise data integrity and process-improvement issues, and recommend resolutions as needed.
Coordinate and communicate study activities to ensure timely delivery of partner milestones.
Collaborate with Bioinformatics, Data Management, Clinical Operations, Lab Operations, and Technology on report release and holding, report templates and IXRS transfers, daily study-specific reporting workflows and TAT, partner relationship management, and internal technology solutions involving WLM, BI, PRA, Partner Portal, and CRM.
Perform other duties as assigned.
Comply with FMI's attendance policies.