Senior Clinical Data Manager/Principal Clinical Data Manager

July 11

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Logo of pfm medical, inc.

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

• Oversees all aspects of the clinical trial data management process • Manage database development and testing • Develop CRF specifications and coordinate review/feedback • Conduct database build UAT and maintain quality controlled database build documentation • Specify requirements for edit checks and oversee development of edit check specifications • Responsible for creating, revising, versioning, and maintaining data management documentation • Train clinical research personnel on study-specific items • Review and query clinical trial data according to the Data Management Plan • Run patient and study level reporting • Coordinate SAE/AE reconciliation • Liaise with third-party vendors in a project-manager capacity • Identify and troubleshoot operational problems for studies based on metrics data • Participate in the development and maintenance of SOPs related to data management activities • Provide leadership for cross-functional and organization-wide initiatives • Communicate with study sponsors, vendors, and project teams regarding project issues • Requires some travel • Perform other duties as assigned

Requirements

• Bachelors and/or a combination of related experience • Must have worked as a Lead Data Manager for a Clinical Research Organisation • 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

• N/A

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