Good Clinical Practice (GCP)ICH guidelinesFDAEMACDISCSDTM
Full Job Posting
Accountabilities and Responsibilities:
Clinical Data Management Leadership
Lead and oversee all clinical data management activities for assigned clinical trials from protocol development through database lock and study closeout.
Develop and execute data management strategies that support program timelines, quality objectives, and regulatory submission readiness.
Ensure consistent application of Good Clinical Practice (GCP), ICH guidelines, company SOPs, and industry best practices.
Provide leadership and guidance to CROs and vendors performing outsourced data management activities.
Vendor and CRO Oversight
Serve as the primary sponsor representative for outsourced data management activities.
Establish governance and performance oversight processes, including KPIs, quality metrics, and issue escalation pathways.
Review and approve vendor deliverables, including: Data Management Plans CRF specifications Edit Check Specifications Data Review Plans Database Validation Documentation Data Transfer Specifications Reconciliation Plans
Data Management Plans
CRF specifications
Edit Check Specifications
Data Review Plans
Database Validation Documentation
Data Transfer Specifications
Reconciliation Plans
Monitor CRO performance and ensure accountability for quality, timelines, and budget adherence.
Data Quality and Inspection Readiness
Establish and monitor key study metrics related to data quality, data cleaning, query management, and database readiness.
Lead ongoing review of data trends and identify risks requiring mitigation.
Ensure audit and inspection readiness through comprehensive documentation and process compliance.
Support internal audits and health authority inspections as the data management subject matter expert.
Cross-Functional Collaboration
Serve as the Data Management representative on Clinical Study Teams and Development Teams.
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Effectively communicate study status, risks, mitigation plans, and performance metrics to leadership.
Foster strong collaborative relationships with internal teams and external partners.
Process Improvement
Identify opportunities to improve clinical data management processes, systems, and efficiencies.
Contribute to the development and maintenance of SOPs, work instructions, templates, and best practices.
Support implementation of innovative technologies and risk-based approaches to data management.
Requirements: Proven Experience, Skills, and Education:
Minimum 8+ years of clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
Minimum 3+ years of leadership experience overseeing clinical data management activities and vendor relationships.
Experience supporting Phase 2, Phase 3, and regulatory submission programs.
Experience overseeing outsourced clinical data management models.
Strategic thinker with strong operational execution skills.
Excellent vendor management capabilities.
Effective problem-solving and risk management abilities.
Excellent written and verbal communication skills.
Commitment to patient-focused drug development and data quality excellence
Rare disease experience preferred.
Strong understanding of:
ICH-GCP
FDA and EMA regulations
CDISC standards (SDTM and related submission requirements)
Clinical trial data lifecycle
Risk-based quality management principles
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!
About Us
Pipeline
X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.
Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new hires must have received their complete dose of the COVID-19 vaccine, unless they have been granted an exemption.
About X4 Pharmaceuticals
Biotechnology143 employeesFounded 2014
Develops and commercializes therapies for rare immune system diseases.
