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 Associate CDM to join its Data Management team. This position will be responsible for assisting Clinical Data Managers in all aspects of clinical data management tasks. Activities will include but are not limited to initial and double data entry, reconciliation of paper CRFs and EDC records, proper notation of data changes in the audit log, and ensuring accuracy and consistency of the data.
Responsibilities
- Assist the Clinical Data Managers (CDMs) in any assigned clinical data management tasks across multiple studies.
- Exhibit a high attention to detail in all tasks assigned.
- Complete tasks within requested timelines and communicates task completion CDMs.
- Perform review of data discrepancies and issues/assigns queries as outlined in SOPs.
- Resolve assigned queries as outlined in SOPs.
- Maintain proper documentation of data management activities.
- Extract, reformat, and analyze simple datasets in Excel or Access format.
- Perform other duties as assigned.
Qualifications
- Education: Bachelor’s degree.
- Experience: A minimum of two years of professional work experience; experience in clinical data entry preferred.
- Knowledge of clinical data management processes and GCPs preferred.
- Computer literacy and proficiency in MS Office Suite.
- Ability to organize and multi-task with a strong attention to detail.
- Excellent communication, organization and time management skills.
- Must be self-motivated and perform excellent work with limited direct oversight/guidance.
- Ability to raise, discuss and resolve concerns and issues with superiors.
- Must be able to adapt to shifting priorities.
- Must have strong interpersonal skills and the ability to work in a team environment.
- Exposure to EDC systems a plus.
- Demonstrates ethical thinking in all actions.
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.
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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.
