Clinical Trial Manager

November 8

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RQM+

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Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device

501 - 1000

Description

• RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. • Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services. • The Clinical Trial Manager (CTM) is responsible for the successful planning, implementation, and execution of contracted clinical monitoring activities. • Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. • Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by RQM+ and its clients.

Requirements

• BS/BA (or equivalent) in one of the life sciences and a minimum of 5 years direct experience in clinical studies • Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis • Minimum of 1 year as a successful Lead CRA or Clinical Trial Manager. • Equivalent combination of education, training, and experience • Thorough knowledge of clinical research process. • Strong communication skills (verbal and written) to express complex ideas. • Excellent organizational and interpersonal skills. • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. • Ability to manage multiple priorities within various clinical trials. • Ability to reason independently and recommend specific solutions in clinical settings. • Understanding of basic data processing functions, including electronic data capture. • Working knowledge of current ICH GCP guidelines and applicable regulations • Ability to work independently, prioritize and work with a matrix team environment. • Working knowledge of Word, Excel, and PowerPoint. • Prior experience in electronic data capture (EDC) preferred. • Ability to mentor CRAs. • Willingness and ability to travel domestically and internationally, as required.