Data Manager Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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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 and serve as the primary Data Management point of contact for assigned studies • Ensure contracted Data Management deliverables are met with a focus on quality and timeliness • 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 cross-functional stakeholders across global regions • Manage and coordinate the integration and utilization of ancillary systems • Identify risks and issues impacting study delivery, define mitigation strategies, and drive issue resolution • Review and analyze study metrics to identify trends and summarize study health • Review Master Services Agreements, Service Level Agreements, and contracts to manage sponsor-specific metrics and Key Performance Indicators • Attend cross-functional meetings and prepare agendas, meeting minutes, action logs, and decision logs • Demonstrate technical and operational Data Management expertise in bid pursuits and proposals • Provide input for bid pursuit presentations and materials • Represent Data Management during sponsor presentations • Ensure compliance with Standard Operating Procedures and ICH/GCP guidelines • Maintain inspection-ready Trial Master Files • Identify and document quality issues and ensure appropriate resolution and closure • Prepare for and participate in internal, sponsor, and regulatory audits and inspections • Drive and implement corrective and preventive actions and share lessons learned • Collaborate with Delivery Leads and line management on project resourcing and staff assignments • Identify and request functional resources required for project delivery • Support resolution of Data Management-related project variances, including scope changes • Provide Data Management input to organizational initiatives and feedback on initiatives • Ensure management system information is accurate and up to date • Maintain required training compliance, including on-the-job training • Deliver project-specific training to internal Data Management teams • Support development goals and training needs • Provide on-the-job training when needed • The Data Manager II may provide mentorship to Assistant Data Managers and Data Management peers

🎯 Requirements

• Strong experience within the clinical research industry • 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 • Strong 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 with the ability to build rapport and trust • Commitment to quality with a methodical and accurate approach to work • Strong time management and prioritization skills • Proven 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 work arrangement • On-the-job training • Project-specific training • Support for identified development goals and training needs • Equal opportunity employment