Associate, Clinical Data Operations

Foundation Medicine, Inc.; Boston (MA); In loco; USD 53.000 - 67.000; Tempo pieno

Vantaggi offerti da questo lavoro

Foundation Medicine benefits

Descrizione del lavoro

Foundation Medicine, Inc. seeks a Clinical Data Operations Associate in Data Management to support study operations, data entry, and reporting for BioPharma, FMI, and Academic Collaborator trials.

You will ensure accurate sample tracking, manage queries, and maintain study data across FMI systems while adhering to HIPAA and data privacy standards. This role emphasizes collaboration with Bioinformatics, Clinical Operations, and Lab Operations to deliver timely partner milestones and drive process

Competenze

• Bachelor's Degree in a health or science field.
• 1+ year of professional work experience in science or health industries.
• Familiarity with oncology, clinical research, molecular biology, genetics and/or bioinformatics.
• Proven ability to work under deadline pressure.
• Strong attention to detail and cross-functional teamwork.
• Excellent verbal and written communication skills.
• Understanding of HIPAA and patient data privacy.

Mansioni

• Provide ongoing study operational support.
• Set up folder structures for new studies in study repository/TMF.
• Monitor archiving of study documentation.
• Track sample processing and deliver SST reports to leads.
• Monitor query process and obtain missing information.
• Enter and maintain study data in FMI systems.
• Coordinate sample returns and destruction for partners.
• Ensure data quality and compliance with HIPAA, GDP, and GCP.
• Collaborate with Bioinformatics, Data Management, Clinical Operations, Lab Operations and Technology to meet timelines.

Conoscenze

Attention to detail

Cross-functional collaboration

Communication skills

Data entry accuracy

Problem solving

Formazione

Bachelor's degree in health or science

Descrizione del lavoro

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 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.
• 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 FMI’s 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.

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