Senior Clinical Data Manager

🕒 Junho 9

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $75.000.000 Private Equity Round em 2015-12

Healthcare • Consulting • Logistics

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • Oversee and/or perform database development and testing. • Ensure that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing. • Ensure that clinical data management deadlines are met with quality. • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders. • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM. • Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables. • May assist with SAS programming and quality control of SAS programs used in the Data Management department.

🎯 Requisitos

• Bachelors and/or a combination of related experience • Ability to communicate both verbally and in writing at the English proficiently (Professional level) • 8+ years’ experience OR Combination of qualifications and equivalent relevant experience may be accepted as an alternative. • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Excellent organizational and communication skills • Professional use of the English language; both written and oral • Experience in utilizing various clinical database management systems • Broad knowledge of drug, device and/or biologic development and effective data management practices • Strong representational skills, ability to communicate effectively orally and in writing • Strong leadership and interpersonal skills • Ability to undertake occasional travel

🏖️ Benefícios

• Employee health insurance • Paid time off • Professional development opportunities