Senior Clinical Data Operations Specialist

Foundation Medicine, Inc.; Morrisville (NC); Hybrid; USD 63,000 - 74,000; Full time

Benefits offered by this job

Hybrid work environment

Job summary

Foundation Medicine, Inc. in Boston, MA, is seeking a Sr. Associate, Clinical Data Operations to support data management activities across BioPharma, FMI and Academic Collaborator trials.

You will handle sample tracking, data entry, query management and reporting to ensure timely, accurate data. The role collaborates with Bioinformatics, Data Management, Alliance Management, Clinical Operations and Technology, requiring a proactive, detail-oriented approach.

Qualifications

• 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.

Responsibilities

• Provide data reporting and study operational support.
• Set up folder structure for all new studies in study repository/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).
• 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 and 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 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 reporting and template transfers, daily study reporting, CRM, WLM, BI and PRA.
• Other duties as assigned.
• Comply with FMI's attendance policies

Skills

Cross-functional collaboration

Communication

Attention to detail

Time management

Problem solving

Adaptability

Self-motivation

Education

Bachelor's degree in science or related field

Tools

MS Office

Job description

Foundation Medicine, Inc. in Boston, MA, is seeking a Sr. Associate, Clinical Data Operations to support data management activities across BioPharma, FMI and Academic Collaborator trials.

You will handle sample tracking, data entry, query management and reporting to ensure timely, accurate data. The role collaborates with Bioinformatics, Data Management, Alliance Management, Clinical Operations and Technology, requiring a proactive, detail-oriented approach.