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Clinical Program Lead

Full Time | Boston | Massachusetts | United States

About the Job

The Associate, Clinical Operations provides comprehensive operational support for FMI’s clinical trials. The incumbent is responsible for trial components specific to Comprehensive Genomic Profiling (CGP), including day-to-day project management, study planning, specimen tracking, and resource management. The incumbent works collaboratively with internal and external teams across a number of functions to manage timelines and critical path activities, directly impacting the successful implementation and ongoing execution of FMI’s clinical trials.

 

 

Key Responsibilities

• Support daily activities of multiple clinical trials under the leadership and mentorship of Clinical Operations study managers.

• Work closely with cross-functional teams to assist with sample receipt and accessioning, including proper specimen handling, labeling, and preparation for processing.

• Ensure progress against executed collaboration agreements, proactively identifying and raising issues and providing recommendations for resolutions.

• Perform data entry into existing or new systems to track and problem solve sample status from receipt to processing, analysis, reporting and interpretation.

• Maintain database of key study contacts available to address all sample related inquiries and issues, and periodically outreach to contacts for problem solving clinical operations issues.

• Ensure appropriate follow-up of all team members in the execution of objectives and escalate issues to the appropriate parties.

• Other duties as assigned.

 

 

Qualifications

Basic Qualifications

• Bachelor’s Degree

• 1+ year of professional experience within the biopharmaceutical or diagnostic industry or in an academic cancer center

• 2+ years of clinical trial or data coordination experience

 

Preferred Qualifications

• Advanced Degree in a business or scientific discipline

• Experience managing clinical trials

• Strong organizational skills

• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow in a fast-paced, dynamic environment

• Demonstrated evidence of success working in a cross-functional environment; able to build strong relationships

• Knowledge and experience working in MS Office Suite

• Understanding of HIPAA and importance of patient data privacy

• Ability to work well under pressure while maintaining a professional demeanor

• Excellent organization and attention to detail

• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

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Internal applicants, please use your FMI email address.

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