Data Management Lead

🔥 16 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Provides technical expertise across all aspects of Data Management • Serves as the primary Data Management point of contact for assigned studies • Ensures contracted Data Management deliverables are met with a focus on quality and timeliness • Manages study data delivery timelines, including Go-Live, Interim Deliveries, and Final Database Lock • Collaborates closely with cross-functional teams across global geographies • May provide mentorship to Assistant Data Managers and Data Management peers • Reviews and analyzes study metrics to identify trends and summarize study health • Reviews agreements to manage sponsor-specific metrics and performance indicators • Attends cross-functional meetings and prepares meeting minutes and action logs • Ensures compliance with Standard Operating Procedures and ICH/GCP guidelines • Identifies quality issues, ensuring appropriate resolution and closure. • Participates in internal, sponsor, and regulatory audits and inspections.

🎯 Requirements

• 6+ years of hands on Clinical Data Management experience • Proven experience leading project and program teams • Good understanding of project tools, reports, and processes related to project financial management, including forecasting, revenue recognition, scope of work, and departmental budgets • Good understanding of Clinical Study Team roles outside of Data Management • Strong knowledge and application of ICH-GCP guidelines, local regulatory requirements, Standard Operating Procedures, and study-specific procedures • Awareness of SDTM, CDISC, and CDASH standards • Strong technical proficiency with Clinical Trial/Data Management Systems such as InForm, Rave, Veeva, DataLabs, and Microsoft Office applications • Written and spoken fluency in English.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options