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pfm medical, inc.
pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1
Medical Device Manufacturing
11 - 50
Senior Clinical Data Manager - Principal Clinical Data Manager
August 8
pfm medical, inc.
pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1
Medical Device Manufacturing
11 - 50
Description
• Responsible for managing clinical trial data management process from start to post database lock • Primary Data Management contact for assigned projects, ensuring timely task performance and continuity • Oversee project data entry process, including guidelines and quality • Perform quality control of data entry as needed • Assess and manage project timelines, ensuring clinical data management deadlines are met • Develop CRF specifications from clinical study protocol • Conduct database build UAT and maintain quality documentation • Create and maintain data management documentation for Trial Master File • Train clinical research personnel as needed
Requirements
• Bachelors and/or a combination of related experience • 8+ years’ experience for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager • 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
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation
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