Senior Clinical Data Manager

🕒 Abril 1

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $100.000 - $125.000 / ano

⏰ Tempo Integral

🟠 Sênior

📊 Cientista de Dados

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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eClinical Solutions

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2012

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

💰 Private Equity Round em 2020-01

Biotechnology • Pharmaceuticals • Healthcare Insurance

A eClinical Solutions é uma empresa de gestão de dados clínicos que fornece soluções integradas de revisão e gestão de dados para as indústrias de biotecnologia e farmacêutica. Sua plataforma, elluminate, capacita as organizações a modernizar e automatizar seus fluxos de trabalho de dados clínicos, garantindo uma aquisição, gestão e análise de dados eficientes. Ao aproveitar análises avançadas e abordagens impulsionadas por tecnologia, a eClinical Solutions ajuda a simplificar as operações de ensaios clínicos e melhorar a produtividade, permitindo uma melhor tomada de decisão na pesquisa clínica.

Descrição

• Primary representative for eClinical Solutions and sponsor data management interaction • Responsible for monitoring and ensuring adherence to study timelines and deliverables • Accountable for the overall quality of data management activities and deliverables at the study or program level • Ensure efficiency and consistency for data management tasks across programs • Communicate with global study teams • Participate in client study kickoff and closeout/lessons learned meetings • Create materials for and present at Investigator Meetings • Develop content and deliver Sponsor CRA and/or site training • Delegate tasks, support and provide guidance to study data management team • Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text • Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications • Participate in Internal System Testing (IST) on the database/user roles/edit check specifications • Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting • Utilization of centralized data management platform including graphical patient profiles and operational analytics • Compile the sponsor UAT package • Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications • Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools • Oversee and/or perform data review for overall consistency and accuracy • Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database • Oversee and/or perform query processing/resolution • Provide ongoing data management reports and metrics • Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study • Define and develop specifications for database, programming and/or edit check changes as needed throughout the study • Track data management issues and ensure follow up to resolution • Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan • Maintain data management study documentation • Perform steps pertaining to database freeze/lock and coordinate all related activities • Ongoing evaluation of process and participate in process improvement • Assist in the creation and review of SOPs, WIs, and training materials • Mentor junior level staff and peers on all associated tasks within a study • Participate in proposal defenses • Perform other duties as requested by management

🎯 Requisitos

• Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred • 8+ years in Clinical Data Management experience preferred • Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology • Strong project management experience and project team leadership skills including work planning and work delegation • Experience with EDC and performing data management activities • Excellent verbal and written communication skills • Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel • Experience with EDC and Clinical Data Management Systems

🏖️ Benefícios

• Health insurance • 401(k) matching • Paid time off • Flexible work arrangements • Professional development opportunities