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.
Responsibilities
- Develop project specific data management plans and other related documentation.
- Review reports, listings, and other documents generated in data management for distribution to sponsor, investigators and their study support staff.
- Ensure overall quality, integrity, and timely completion of assigned projects within data management.
- Serve as the primary project contact for data management with client/sponsor.
- Perform data entry in any applicable clinical data management system.
- Prepare data for entry through completion of transmittal verification and data tracking.
- Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data entry processes.
- Build and maintain EDC systems for clinical studies.
Qualifications
- Education: Bachelor’s degree in a scientific, computer or related discipline.
- Experience: Minimum 4-5+ years of experience in clinical data management with experience in medical device studies
- 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $82,300.00 - $137,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
