Senior Project Manager, Clinical Trials

October 25

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Logo of RQM+

RQM+

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. • Responsible for the successful planning, implementation, and execution of contracted activities. • Assures the accurate transfer of contracts from proposal through project completion. • Functionally responsible for all team members throughout the duration of each clinical trial. • Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by RQM+ and our sponsors. • Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.

Requirements

• Previous management experience required. • Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with at least five (5) years direct clinical trial experience in a CRO or research-related organization with at least two (2) years management experience OR equivalent level of education and experience. • Global project management experience within the medical device, diagnostic, SaMD development industry, with previous CRO experience is ideal. • Previous experience in managing people within a scientific/clinical environment is required. • Demonstrated Clinical Monitoring and/or Data Management experience required. • Demonstrated financial management skills required. • Very limited physical effort required to perform normal job duties. • Up to 20% travel may be required including international travel. • Must be able to secure a credit card co-signed by RQM+. • Thorough knowledge of clinical research process from pre-clinical through regulatory submission, approval and post-approval. • Strong communication skills (verbal and written) to express complex ideas. • Excellent and demonstrated 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 a variety of complex clinical trials. • Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings. • Ability to set baseline targets, track trends and implement mitigation plans. • Understanding of basic data processing functions, including electronic data capture. • Demonstrated problem-solving and financial negotiation skills. • Excellent verbal and written communication and presentation skills required. • Working knowledge of current ICH GCP guidelines. • The ability to work independently, prioritize and work within a matrix team environment is essential. • Working knowledge of Word, Excel, and PowerPoint required. • Prior experience in electronic data capture preferred.

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