Associate, Clinical Data Operations
About The Position
The Clinical Data Operations Associate in Data Management performs activities supporting functional processes and contributes to ongoing department process improvement, knowledge management, and training initiatives. The role provides operational and tactical support for BioPharma, FMI, and Academic Collaborator clinical trials, including accurate sample tracking, collection of accurate sample information from partners, query management and resolution, data entry for complex studies, timely data reporting, and coordination of sample returns. The position works closely with internal and external FMI teams. The associate supports study operations and documentation, tracks sample processing and reports sample status, coordinates partner queries and sample returns, and manages study sample data in FMI systems. The role performs quality control of partner data, helps ensure compliance with HIPAA, GDP, and GCP, identifies data integrity and process issues, and coordinates activities across teams to meet partner milestones. The position is based in Boston, Massachusetts.
Requirements
- Bachelor’s degree in a health or science field.
Nice To Haves
- At least 1 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.
- Strong attention to detail.
- 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.
Responsibilities
- Provide ongoing study operational support.
- Set up folder structures for new studies in the study repository/Trial Master File (TMF).
- Monitor archiving of study documentation in the study repository/TMF during studies 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 the query process and query partners/collaborators to obtain missing information.
- Complete Study Intake information in the CRM/Clinical Trial Management System.
- Manage sample returns and destruction 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 quality standards are met, including compliance with HIPAA, GDP, and GCP.
- Identify and raise data integrity and process improvement issues, and recommend resolutions as needed.
- Coordinate and communicate relevant study activities to ensure timely delivery of partner milestones.
- Collaborate with Bioinformatics, Data Management, Clinical Operations, Lab Operations, and Technology on report releases and holds; report template and IXRS transfers; daily study-specific reporting workflows and TAT deliverables; 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.
Benefits
- Eligibility for Foundation Medicine benefits.
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
