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's integrated application of these key value-creating functions provides unparalleled expertise for its clients. 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.
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
- 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.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
What We Do
MCRA is a highly specialized, independently operated consulting firm and Clinical Research Organization (CRO) serving the worldwide medical device industry. MCRA is a group of leading strategists committed to integrating regulatory, clinical, reimbursement, quality assurance, and healthcare compliance strategies to facilitate successful value creation for our clients. Founded in 2003, the firm provides “first-in-class” service to its clients through its superior knowledge base, global surgeon relationships, and deeply experienced management team. 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.
Our mission is to be the most experienced musculoskeletal strategic advisory team to guide our clients' products through the regulatory, clinical research, reimbursement, compliance and quality assurance processes quickly and successfully, to create maximum value for their shareholders.
Our vision is to be the market leading medical device advisory firm. Recognized as the market leading provider of regulatory, reimbursement, clinical research, compliance, quality assurance, and hospital services, MCRA’s vision is to provide the same leading quality of services throughout the medical device industry.
