Precision Medicine Group
1001 - 5000 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $35.2M Venture Round on 2021-03
Biotechnology • Healthcare Insurance • Pharmaceuticals
Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.
Clinical Data Manager II – Senior Clinical Data Manager
🔥 0 minutes ago
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Precision Medicine Group
1001 - 5000 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $35.2M Venture Round on 2021-03
Biotechnology • Healthcare Insurance • Pharmaceuticals
Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.
📋 Description
• Responsible for managing all aspects of the clinical trial data management process from study start up to post database lock • Primary Data Management (DM) contact for assigned clinical project(s), ensuring continuity and timely task performance • Oversee project data entry process including development of data entry guidelines, training, and quality • Provide input, assess and manage timelines to ensure clinical data management deadlines are met • Develop CRF specifications from clinical study protocols and coordinate feedback from stakeholders • Conduct database build UAT and maintain quality controlled database build documentation • Specify requirements for all edit check types and oversee the development of specifications • Train clinical research personnel on project related items • Review and query clinical trial data according to the Data Management Plan • Run patient and study level status and metric reporting • Coordinate SAE/AE reconciliation • Liaise with third-party vendors in a project manager capacity • Identify and troubleshoot operational problems based on metrics data
🎯 Requirements
• Bachelors and/or a combination of related experience • 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company • Set up and Database migrations experience • Oncology experience preferred • 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
🏖️ Benefits
• Work from home opportunities • Flexible work arrangements
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