Data Management Lead

🕒 July 13

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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👻 Ghost score 45%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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

• Provide technical expertise across all aspects of Data Management • Serve as the primary Data Management point of contact for assigned studies • Ensure contracted Data Management deliverables meet quality and timeliness requirements • Manage study data delivery timelines, including Go-Live, Interim Deliveries, and Final Database Lock • Collaborate with Clinical, Biostatistics, Database Programming, Medical, Medical Writing, and other global stakeholders • Manage and coordinate integration and utilization of ancillary systems • Identify study delivery risks and issues, define mitigation strategies, and drive resolution • Review study metrics, identify trends, and summarize study health • Review agreements and contracts to manage sponsor-specific metrics and KPIs • Attend cross-functional meetings and prepare agendas, minutes, action logs, and decision logs • Provide Data Management expertise and input for bid pursuits, proposals, and sponsor presentations • Ensure compliance with SOPs and ICH/GCP guidelines • Maintain inspection-ready Trial Master Files • Identify and document quality issues and ensure resolution and closure • Prepare for and participate in audits and inspections • Drive corrective and preventive actions and share lessons learned • Collaborate on project resourcing, staff assignments, and functional resource requests • Support resolution of project variances and scope changes • Provide input to organizational initiatives and maintain accurate management-system information • Maintain training compliance and deliver project-specific training • Support development goals and provide on-the-job training when needed

🎯 Requirements

• 6+ years of hands-on Clinical Data Management experience • Strong experience within the clinical research industry • Hands-on Data Management expertise across startup, conduct, and closeout phases • Experience authoring/coauthoring standard Data Management documents • Hands-on experience working in Medidata Rave • Proven experience leading project and program teams • Understanding of project tools, reports, and processes related to project financial management, including forecasting, revenue recognition, scope of work, and departmental budgets • 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 • Technical proficiency with Clinical Trial/Data Management Systems such as InForm, Rave, Veeva, DataLabs, and Microsoft Office applications • Ability to lead and collaborate with global teams across multiple time zones and cultures • Strong negotiation and influencing skills • Excellent interpersonal, written, and verbal communication skills • Strong learning agility and knowledge-sharing mindset • Flexibility and adaptability in changing environments • Effective presentation skills • Strong customer focus and ability to build rapport and trust • Commitment to quality and methodical, accurate approach to work • Strong time management and prioritization skills • Problem-solving and root cause analysis capabilities • Strong sense of ownership and accountability • Ability to travel as required • Written and spoken fluency in English • Bachelor’s degree and/or other qualifications in a science or clinical-related field

🏖️ Benefits

• Remote-based role • Opportunity to contribute to therapies that benefit patients • Mentorship and training opportunities • Support for identified development goals and training needs • Equal opportunity employment