Lead Clinical Data Manager

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Fresh Prints

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2013

🛒 Retail

🛍️ eCommerce

👥 B2C

Retail • eCommerce • B2C

Fresh Prints is a company specializing in custom collegiate merchandise. They offer a wide range of apparel including hoodies, shirts, sweaters, and sweatpants, catering primarily to college students and organizations such as fraternities and sororities. Customers can customize their garments using Fresh Prints' design tool and upload their own inspirations for a personalized touch. The company operates online and is based out of New York City. They are actively engaged with their community through social media and an interactive blog, and they provide opportunities for students to become campus managers, enhancing their presence in the collegiate community.

📋 Description

• Lead all sponsor-side data management activities for Phase 2/3 clinical trials in rare disease and neonatology. • Develop and execute data management strategies aligned with clinical development, regulatory, and submission timelines. • Act as the primary point of contact for all data management deliverables across internal teams and external partners. • Provide oversight of data management activities conducted by CROs and other vendors within a fully outsourced operating model. • Manage relationships with CROs, electronic data capture (EDC) providers, central laboratories, imaging vendors, and other specialty vendors. • Review and approve key data management documents, including Data Management Plans (DMPs), Data Validation Plans, Edit Check Specifications, Data Transfer Agreements, Database Design Specifications, User Acceptance Testing (UAT) documentation. • Monitor vendor performance against scope, budget, quality metrics, and timelines. • Lead data governance meetings and escalate risks and issues as appropriate. • Oversee database build, testing, deployment, maintenance, and database lock activities. • Ensure data review, query management, coding, reconciliation, and cleaning activities are performed in accordance with study timelines and GCP. • Oversee the coordination of external data integrations, including laboratory, safety, pharmacokinetic, and device data. • Lead internal cross-functional data review meetings and drive resolution of data discrepancies. • Ensure compliance with ICH-GCP, FDA, EMA, and applicable global regulatory requirements. • Maintain inspection readiness for clinical data management processes and deliverables. • Support preparation of regulatory submissions, including NDA/BLA/MAA packages. • Contribute to development and continuous improvement of SOPs, work instructions, and quality systems. • Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. • Provide data management expertise during protocol development and study start-up activities. • Assess protocol feasibility and identify operational risks related to data collection in neonatal and rare disease populations. • Present study status, risks, and mitigation plans to senior leadership and governance committees.

🎯 Requirements

• Bachelor's degree in Life Sciences, Biostatistics, Computer Science, Nursing, Public Health, or a related discipline; advanced degree preferred. • Minimum 12-15 years of clinical data management experience within the biotechnology, pharmaceutical, or CRO industry. Strong preference for biotechnology experience. • Demonstrated experience leading global Phase 2/3 clinical trials. • Demonstrated experience leading DM activities for Inspection Readiness. • Significant sponsor-side experience operating within a fully outsourced clinical development model. • Experience supporting regulatory submissions (NDA, BLA, MAA). • Prior experience with rare disease and/or pediatric or neonatal clinical studies. • Strong knowledge of EDC platforms such as: Medidata Rave, Oracle InForm, Veeva Vault CDMS. • Experience with CDISC standards, including SDTM and controlled terminology. • Familiarity with electronic clinical outcome assessments (eCOA), laboratory data transfers, and safety reconciliation. • Understanding of data visualization and review tools. • Knowledge of risk-based quality management principles.

🏖️ Benefits

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