Associate Director, Data Management
Company: Disability Solutions
Location: Boston
Posted on: September 4, 2024
Job Description:
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
Keywords: Disability Solutions, Boston , Associate Director, Data Management, Executive , Boston, Massachusetts
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