About the Job

The Associate Director, Data Management oversees data management for FMI's BioPharma and Academic research collaborations, in addition to FMI sponsored research. This position supervises the data management team, provides training and mentorship to team members, and manages the day-to-day projects and resources within the team. This role contributes to the development and implementation of the Data Management strategy and ensures consistent implementation and evolution of processes and procedures in support of Clinical Trials. The Associate Director is the primary liaison between Data Management and FMI's Information Technology teams. The incumbent also supports relationships with FMI’s Laboratory, Biopharma and Academic Clinical Operations and Computational Biology teams, as well as external partners’ project teams.

This position requires the ability to travel nationally and internationally (up to 10%).

This job is located in Cambridge, MA, and is eligible for immigration sponsorship.

Key Responsibilities

• Lead a team of data management personnel, mentoring, and supporting their ongoing professional development and growth.
• Manage, review, and approve new Data Management work for our Biopharma and Academic partnerships.
• Oversee daily deliverables for our research collaborations.
• Facilitate team meetings by creating agendas, identifying priorities/working groups, and distributing communications/minutes
• Act as the key point of contact for FMI's Information Technology teams to propose, prioritize, test, and implement improvements to FMI’s data reporting applications.
• Support external messaging with respect to FMI technology updates.
• Develop scalable solutions to enhance technical support for data management processes.
• Strategically represent Data Management on cross-FMI initiatives and governance committees (LCT).
• Support development and maintenance of Clinical Trial Data Operations Standard Operating Procedures (SOPs) and WIs.
• Assist with prioritization of Data Operations deliverables and technology requests.
• Provide point of escalation support to team.
• Act as Data Management's subject matter expert during audits from partners and regulatory agencies.
• Maintain occasional availability to work outside of regularly scheduled shift.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree or equivalent in scientific field or equivalent combination of education, training, and experience with 9+ years of data management experience in a biotech, pharmaceutical, or Clinical Research Organization (CRO) environment handling complex clinical data sets including genomic data and experience in oncology trials; OR
• Master’s degree or equivalent in scientific field or equivalent combination of education, training, and experience with 7+ years of data management experience in a biotech, pharmaceutical, or Clinical Research Organization (CRO) environment handling complex clinical data sets including genomic data and experience in oncology trials
• 5+ years of experience with direct people management or leading a team

Preferred Qualifications

• Master’s Degree
• Experience working within Good Clinical Practices, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Clinical Data Interchange Standards Consortium (CDISC) and other necessary guidelines
• Experience in a CRO or clinical research vendor environment
• Experience in scientific data management in all phases of project design and analysis
• Experience with cross-functional collaboration and facilitating strategic and tactical planning for excellent interaction with outside collaborators and clients
• Familiarity with Study Data Tabulation Model/STDM
• Ability to help scale functional areas to include additional data responsibilities and team members
• Demonstrated ability to effectively communicate, influence, and lead both with and without authority
• Demonstrated ability to perform both at a strategic leadership level as well as in a hands-on capacity
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow in a fast-paced, dynamic environment
• Demonstrated ability to learn new software and technology quickly
• Demonstrated ability to work under pressure while maintaining a professional demeanor
• Proven demonstration of leadership, strategic, and system thinking
• History of applying proactive, forward thinking to problems
• Genomic data background and experience
• Technical proficiency in using relational databases
• Excellent communication skills, including ability to diffuse difficult conversations
• Understanding of HIPAA and the importance of maintaining patient document privacy
• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

#LI-Hybrid