Senior Lead Data Manager

🕒 Abril 3

🌪️ Kansas – Remoto

🌪️ Kansas – Remote

💵 $65.660 - $87.548 / ano

⏰ Tempo Integral

🟠 Sênior

📊 Cientista de Dados

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Altasciences

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1998

🧬 Biotecnologia

💊 Farmacêutico

💰 Private Equity Round em 2017-06

Biotechnology • Pharmaceuticals

Altasciences é uma organização de pesquisa contratada de médio porte e visionária, especializada na fase inicial de desenvolvimento de medicamentos, localizada no Canadá e nos EUA, atendendo empresas biofarmacêuticas de todos os tamanhos. A empresa é especializada em oferecer uma abordagem flexível para o desenvolvimento inicial de medicamentos, com serviços que incluem testes de segurança pré-clínicos, farmacologia clínica da Fase I à Fase II, bioanálise do pré-clínico à Fase IV, bem como serviços analíticos de pesquisa e fabricação. A Altasciences está comprometida em acelerar o desenvolvimento de medicamentos nas fases iniciais, garantindo transições suaves da seleção do candidato principal à prova de conceito e além, entregando assim resultados impactantes com um toque pessoal.

Descrição

• Follow department and company standard operating procedures (SOPs), forms, templates and policies. • Provide feedback and update these guidelines as needed. • Act as the primary Data Management contact for the client and project team, proactively managing sponsor and interdepartmental expectations. • Develop strong client relationships that are driven by consistent study delivery in terms of quality and timeliness. • Develop, review, and maintain all study Data Management documentation. • Coordinate with Database Developers to ensure effective database build and timely go-live to meet the needs of the project. • Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. • Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data. • Define electronic case report form (eCRF) and edit check specifications to support data collection and analysis required per protocol. • Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks. • Delegate and collaborate with Data Managers on data management cleaning activities including listing review, issuing and closing queries, and external vendor data reconciliation per protocol, department and client standards, and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines within the timelines expected by the client and project team. • Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and department and sponsor guidelines and that cleaning is effective and timely. • Track eCRFs to ensure appropriate updates and that all missing or discrepant data are queried appropriately. • Monitor key study metrics and provide status reports to the sponsor and project team. • Maintain the Data Management documentation for the trial master file (TMF) according to department and Project Management processes. • Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager. • Provide input into improving the efficiency of data management tasks. • Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives. • Oversee direct reports as assigned. • Mentor and train other team members and/or develop training materials as needed.

🎯 Requisitos

• Bachelor's Degree in programming, health-related sciences, or relevant field and 5-8 years of Data Management experience. • Experience may be considered in lieu of education. • Excellent verbal and written communication skills. • Professional attitude and strong interpersonal skills. • Ability to work well with a multi-disciplinary team of professionals. • Client-focused approach to work. • Flexible attitude with respect to work assignments and new learning. • Ability to prioritize workload. • Superior attention to detail. • Understanding of clinical research and the relationship of Data Management in the clinical study process. • Proven history of continuous improvement. • Strong technical aptitude and ability to adapt to multiple data management platforms. • Strong knowledge of electronic data capture (EDC) clinical data management systems. • Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.

🏖️ Benefícios

• Health/Dental/Vision Insurance Plans • 401(k)/RRSP with Employer Match • Paid Vacation and Holidays • Paid Sick and Bereavement Leave • Employee Assistance & Telehealth Programs • Training & Development Programs • Employee Referral Bonus Program • Annual Performance Review