Clinical Data Manager II/Senior Clinical Data Manager

🕒 Junho 2

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $91.500 - $166.100 / ano

⏰ Tempo Integral

🟠 Sênior

📊 Cientista de Dados

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Precision Medicine Group

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2012

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $35.200.000 Venture Round em 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Precision Medicine Group é uma equipe global de especialistas dedicada à medicina de precisão, que combina ciências laboratoriais avançadas, informática translacional, assuntos regulatórios, insights de pagadores e comunicações de marketing. A empresa foca em superar desafios de desenvolvimento de produtos e de comercialização para clientes dos setores farmacêutico e de ciências da vida. Seus serviços incluem P&D orientada por biomarcadores, bem como suporte à comercialização para organizações de ciências da vida, do lançamento à maturidade do produto. A Precision Medicine Group opera por meio de duas frentes principais: Precision for Medicine e Precision AQ, especializadas em soluções clínicas e comerciais, respectivamente.

Descrição

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • May perform quality control of data entry • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders • May assist in building clinical databases • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. • May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Review and query clinical trial data according to the Data Management Plan • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM • Run patient and study level status and metric reporting • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • 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 • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders • May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities • May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings • May review Request for Proposals (RFP), proposals, provide project estimates • Provide leadership for cross-functional and organization-wide initiatives, where applicable • Trains and ensures that all data management project team members have been sufficiently trained • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues • May present software demonstrations/trainings, department/company training sessions, present at project meetings • May require some travel • Perform other duties as assigned

🎯 Requisitos

• Bachelors and/or a combination of related experience • 8+ years’ experience as a Sr. Clinical Data Manager and 5 Years as a Clinical Data Manager II • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Able to handle a variety of clinical research tasks • 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

• Health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation