Lead Clinical Data Manager – Early Development

🔥 15 hours 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

• Provide technical expertise in all aspects of Data Management • Manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock • Collaborate with relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies • Act as a single point of contact for contracted Data Management deliverables to ensure timeliness and quality • Mentor ADMs or other DM peers • Manage and coordinate the integration and utilization of all ancillary systems • Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan • Review and analyze metrics to derive meaningful summary of study health and trends • Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies • Collaborate with Delivery Lead and/or line management to ensure appropriate project level resourcing of staff • Deliver Project Specific Training to internal DM team

🎯 Requirements

• Strong experience in clinical research industry • Proven record of leading project and program teams • Good understanding and application of Parexel project tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects. • Good understanding of Clinical Study Team roles outside of Data Management • Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures • Awareness of SDTM/CDISC/CDASH standards • Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products • Bachelor’s degree and/or other qualifications in a science or clinical related industry • Minimum 3 years of relevant experience • Must have early development experience

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Flexible work hours • Professional development opportunities