Associate, Clinical Data Operations
Company: Disability Solutions
Location: Boston
Posted on: April 18, 2024
Job Description:
About the Job
The Clinical Data Operations Associate in Data Management performs
operational and tactical support and ensures quality control and
delivery of patient data to FMI's Pharmaceutical and Academic
research partners. The incumbent is responsible for accurate sample
tracking and handling and timely data reporting and data entry that
impacts the successful implementation and ongoing execution of FMI
clinical partnerships. This role works closely with internal teams
at FMI and external partner teams.
--
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.
--
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 values held at FMI: Patients, Innovation,
Collaboration, and Passion
#LI-Hybrid
Keywords: Disability Solutions, Newton , Associate, Clinical Data Operations, Healthcare , Boston, Massachusetts
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