Senior Clinical Data Manager

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Logo of Precision Medicine Group

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

• 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. • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders. • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. • Review and query clinical trial data according to the Data Management Plan • Run patient and study level status and metric reporting • Perform other duties as assigned

🎯 Requirements

• Bachelors and/or a combination of related experience • 8+ years’ experience OR Combination of qualifications and equivalent relevant experience may be accepted as an alternative. • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Ability to communicate both verbally and in writing at the English proficiently (Professional level) • Experience in utilizing various clinical database management systems • Broad knowledge of drug, device and/or biologic development and effective data management practices

🏖️ Benefits

• Health insurance • Retirement plans • Flexible work arrangements • Professional development

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