Senior Clinical Data Manager

🕒 Abril 3

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

📊 Cientista de Dados

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Worldwide Clinical Trials

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials é uma organização global de pesquisa clínica por contrato (CRO) que oferece serviços abrangentes de ensaios clínicos. A empresa é especializada em apoiar estudos em diversas áreas terapêuticas, como oncologia, cardiologia e doenças raras. Com mais de 30 anos de experiência, a Worldwide Clinical Trials enfatiza suporte personalizado e soluções sob medida ao longo de todo o ciclo de vida do desenvolvimento de medicamentos. Seus serviços incluem monitoramento clínico, gestão de dados, recrutamento de pacientes e consultoria regulatória, garantindo precisão e atenção personalizada para cada ensaio clínico.

Descrição

• Oversee, lead, manage, and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction. • Provide fully independent and autonomous leadership of data management services (start up, conduct, and close out) across multiple complex global projects/programs. • Ensure appropriate resources are allocated to complete all DM activities on time and within budget. • Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs). • Ensure effective UAT is performed. • Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, IRT, Central Laboratory). • Oversee data cleaning activities. • Produce metrics to monitor the progress of trial activities. • Ensure all database lock activities are completed on time. • Represent WorldWide DM at both internal and external study meeting calls, including providing input. • Monitor project scope, budgets, and risks and alert DM Management of any concerns. • Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g., during Project Review Meetings). • Collaborate with internal Worldwide departments working on the same project. • Provide feedback on process improvements to DM Management and/or SMEs. • Participate in and lead process reviews. • Provide training, support, and mentorship to other members of the DM department. • Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings.

🎯 Requisitos

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or related discipline — or equivalent relevant experience. • Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries. • Strong knowledge of data management best practices & technologies as applied to clinical trials. • Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams. • Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes. • Strong analytical and problem-solving skills. • Independent and autonomous project oversight skills.

🏖️ Benefícios

• Diverse and inclusive environment • Professional development opportunities