Data Manager

February 15

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MCRA

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MCRA is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client’s industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. MCRA places particular emphasis on its expertise working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.

Clinical Affairs • Quality Assurance • Regulatory Affairs • Reimbursement • Healthcare Compliance

51 - 200 employees

📋 Description

• MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). • MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. • MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. • Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices. • Position Overview: MCRA is seeking an experienced Clinical Data Manager to join as a critical member of the Data Management team. This position will serve as lead data manager on assigned projects. Along with that, they will ensure compliance of projects with all relevant Good Clinical Practice (GCP) guidelines, Good Clinical Data Management Practice (GCDMP) guidelines, Standard Operating Procedures (SOPs), and any applicable regulatory requirements.

🎯 Requirements

• Education: Bachelor’s degree in a scientific, computer or related discipline. • Experience: Minimum 4-5+ years of experience in clinical data management. • Expertise with applicable databases, clinical data management systems, and data management processes and procedures. • Comprehensive and demonstrated knowledge of the conduct of general data management and data management quality control activities for a clinical study. • Ability to read, write, speak and understand English required. • Ensure work meets client and company standards.