Xeris Pharmaceuticals, Inc. · 3 hours ago
Associate Director, Clinical Data Management
Chicago, IL
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$140K/yr - $220K/yr
8+ years expXeris Pharmaceuticals, Inc. is seeking an Associate Director of Clinical Data Management who will play a key role in developing data management strategies and ensuring compliance with regulatory requirements. This role involves leading clinical data management activities, collaborating with various departments, and mentoring junior staff.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Leads and manages all clinical data management (DM) activities including database build, cleaning, reconciliation, and locking activities across multiple clinical trials to ensure timely, accurate, and complete data collection and analyses
Develops and implements data management strategies, processes, and standards in alignment with Good Clinical Practices (GCP) and applicable regulatory guidelines (e.g., FDA, EMA, ICH)
Oversees the review of key data management documents and operational activities (eg. data management plans [DMPs], case report forms [CRFs], CRF completion instructions, data validation specifications, and edit checks) outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements
Participates in clinical vendor selection for external DM vendors including responsibility for review of DM sections of proposals, budgets, statements of work and change orders
Pilots and implements available digital/AI solutions to improve study efficiency and quality of data collection
Collaborates closely with Clinical Research Operations, Medical, Pharmacovigilance, and Biostatistics to ensure seamless data flow and data review leading to clean datasets for analysis
Ensures storage of all DM documents in the trial master file to support inspection
Mentors junior staff and contributes to departmental growth and development
Qualification
Required
Bachelor's degree in life sciences, health informatics, or a related field
Minimum of 8 years of clinical data management experience in the pharmaceutical, biotechnology, or CRO industry, including at least 3 years in a leadership or supervisory role
In-depth knowledge of CDM processes, regulatory standards (FDA, EMA, ICH-GCP), and clinical data standards (e.g., CDISC, SDTM)
Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Zelta), coding dictionaries (e.g., MedDRA, WHO Drug), and data visualization tools
Proven ability to manage multiple projects and vendors simultaneously
Strong leadership, organizational, and communication skills
Experience supporting regulatory submissions
Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications
Position may require periodic evening and weekend work, as necessary to fulfill obligations
Periodic overnight travel
This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week on-site is required. On-site requirements may change at management's discretion
Preferred
Master's or higher degree
Experience supporting regulatory submissions is highly desirable
Benefits
Bonus
Equity
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
201-500 employees
H1B Sponsorship
Xeris Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
John Shannon
CEO and Director
Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
Recent News
2025-12-01
2025-11-08
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