Manager, Database Programming

🕒 2 dias atrás

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $100.000 - $115.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

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Veristat

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

💊 Farmacêutico

🧬 Biotecnologia

🤝 B2B

💰 Private equity em 2021-05

Pharmaceuticals • Biotechnology • B2B

A Veristat é uma empresa de serviços de desenvolvimento clínico que fornece suporte completo e focado em regulamentação para patrocinadores de biofarmacêuticos e dispositivos médicos. A empresa oferece planejamento e condução de estudos clínicos, assuntos regulatórios e suporte a submissões (incluindo NDA/MAA e interações com agências como PMDA), serviços de estatística e biometria, redação médica, farmacovigilância e gestão de projetos para áreas terapêuticas complexas como oncologia, doenças raras, neurologia, biológicos e terapias celulares e genéticas. A Veristat opera como uma parceira B2B para organizações biotecnológicas e farmacêuticas a fim de reduzir riscos de desenvolvimento e acelerar a aprovação regulatória.

Descrição

• Responsible for the operational leadership of Veristat’s Clinical Database Programming (CDP) team(s). • Support of study level strategy. • Development of Clinical Data Management Systems (CDMS) in compliance with statutory regulations and Veristat Standard Operating Procedures.

🎯 Requisitos

• Bachelor’s (or equivalent) degree in related field preferred or 8 years of relevant experience as a database programmer required. • 8 years of clinical data management and/or clinical database programming experience (including leading projects) required. • 3 + years of supervisory experience or 5+ years of lead experience required. • Extensive experience working for a pharma/biotech sponsor or clinical CRO with specific focus on developing and implementing EDC and web reporting tools. • Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff. • Excellent written and oral communication skills including grammatical/technical writing skills and presentation skills. • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical/biotech companies. • Excellent interpersonal, communication, and organizational skills with the ability to work independently as well as in a team environment. • Experience in, and awareness of, current and emerging EDC systems. • Proven track record at delivering projects on time and within budget. • Extensive knowledge of software validation within a clinical research environment. • Experience of data management principles as applied in an EDC environment. • Ability to develop the best project management tools and use of software appropriate to delivery of such a project. • Knowledge and experience of industry regulations and guidelines as pertaining to EDC system deployment and support specifically 21 CFR Part 11. • Knowledge of and experience with implementing CDISC standards. • Knowledge of and experience programming SAS preferred.

🏖️ Benefícios

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans