Clinical Data Manager II / Senior Clinical Data Manager

🕒 Junho 2

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $75.000.000 Private Equity Round em 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• 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. • 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 • 401(k) matching • Paid time off • Discretionary annual bonus