Associate, Clinical Data Operations

Foundation Medicine, Inc.; Morrisville (NC); On-site; USD 53,000 - 67,000; Full time

Job summary

Foundation Medicine, Inc. is seeking an Associate in Clinical Data Operations to support data management for BioPharma, FMI and Academic collaborators. You will help ensure sample tracking, data entry, query resolution, and timely data reporting across complex studies.

The role emphasizes collaboration with internal teams, adherence to HIPAA and regulatory standards, and contributing to process improvements while supporting partner milestones.

Qualifications

• Basic qualifications require a Bachelor's Degree in a health or science field.
• Preferred qualifications include 1+ year of professional work experience in science/health, familiarity with oncology, clinical research, molecular biology or bioinformatics.
• Strong attention to detail and ability to work cross-functionally under deadlines are desired.

Responsibilities

• Provide ongoing study operational support and maintain study folder structures in TMF.
• Monitor archiving, track sample processing, and generate study-specific sample status reports.
• Manage query processes with partners and complete Study Intake in the CTMS/CRM.
• Ensure data quality and HIPAA, GDP, and GCP compliance across reporting activities.
• Collaborate with Bioinformatics, Data Management, Clinical Operations, Lab Operations and Tech teams on reporting workflows.

Skills

Attention to detail

Cross-functional teamwork

Verbal and written communication

Organizational skills

Time management under deadlines

HIPAA compliance knowledge

Education

Bachelor's Degree in health or science

Tools

CRM

Data management systems

Job description

Foundation Medicine, Inc.

Associate, Clinical Data Operations

• 400 Summer Street, Boston, Massachusetts, United States

• Full Time

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.

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 FMIs 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.
• Comply with FMI's attendance policies

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 reflect FMIs values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $53,200 - $66,500 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.