About the Job
The Clinical Data Manager provides day-to-day data management for biopharma and academic partner studies as process data is generated, analyzed and monitored. This role is responsible for formal data transfers and all documentation required per regulation and industry standards. The role serves as a point of contact between Foundation Medicine’s internal cross-functional teams including laboratory functions, Biopharma Operations, Technology, and Computational Biology Teams. The role also acts as a point of contact with external partners’ study teams.
Study Planning and Start-Up
· Author/draft documents related to study start up including but not limited to Data Validation Specifications, Data Transfer Specifications, and Data Management Plans.
Trial Operations and Study Conduct
· Ensure timely documentation and communication of decisions and updates on timelines and deliverables.
· Partner with Clinical Program Leads to ensure timely delivery of a quality data product in line with Partner expectations and contractual deliverables.
· Manage reconciliation requests raised by partners or vendors .
· Assist in programming/configuring deliverables including report templates, biomarkers, and data transfers within FMI software.
· Responsible for study specific data deliverables to FMI's biopharma partners, such as data transfers with pre-established specification(s).
· Maintain data integrity through quality control checks.
· Contribute to study close-out reports including data management reports and close studies within FMI systems.
· Collaborate with Clinical Program Leads on deliverables for assigned FMI partner.
· Act as point of contact for internal collaborations with Clinical Project Leads, FMI Information Technology Team, and special projects within FMI.
· Build and maintain relationships with internal and external stakeholders and provide study updates as needed to Clinical Operations and BioPharma leadership
Process Oversight and Study Compliance
· Provide input to the software development team to improve processes and technology used to perform data transfers and assist in reconciliation efforts.
· Partner with the Information Technology Team to test and implement improvements to the biopharma data reporting systems.
· Assist with prioritization of Data Operations deliverables and technology requests.
· Execute work with adherence to Good Clinical Practice (GCP) requirements and applicable regulations including but not limited to Clinical Laboratory Improvement Amendments (CLIA), College of American Pathology (CAP), and state specific requirements.
· Participate in Standard Operating Procedure (SOP) development and revision.
· Assist study team in audit preparation.
• Bachelor’s Degree or equivalent in a science or health field or equivalent combination of education, training and experience
• 2+years of data management experience in a professional life sciences environment and/or similar experience in a biopharma/academic setting.
• Master’s Degree
• 3+ years of data management experience in a professional life sciences environment and/or similar experience in a biopharma/academic setting.
• 1+ years of professional or academic experience:
· in clinical oncology trials
· in a Clinical Research Organization (CRO) or lab vendor environment
· scientific data management in all phases of project design and analysis
· handling complex clinical data sets including genomic data
• Technical proficiency with relational databases
• Familiarity with:
· Clinical Data Interchange Standards Consortium (CDISC) standards and Study Data Tabulation Model (SDTM) format
· clinical research protocols
• Knowledge of and experience working within Good Clinical Practices, International Conference on Harmonization requirements, Clinical Data Interchange Standards Consortium standards and other guidelines pertinent to clinical data
• Sharp attention to detail and ability to meet long- and short-term deadlines
• Excellent communication skills, including ability to diffuse difficult conversations
• Demonstrated ability to:
· Learn new software
· Work well under pressure while maintaining a professional demeanor
· Prioritize and thoroughly follow up on assigned tasks
· Handle multiple tasks at once and work in a fast-paced environment
· Adapt to changing procedures, policies and work environment
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: Passion, Patients, Innovation, and Collaboration
Internal applicants, please use your FMI email address.