MDC Associates, Inc. · 7 hours ago
Clinical Data Specialist
United States
Full-time
Remote
Entry Level
$70K/yr - $75K/yr
2+ years expMDC Associates, Inc. is a full-service CRO dedicated to supporting innovators in the medical field. The Clinical Data Specialist will manage data-related activities in clinical trials, ensuring high-quality data collection and compliance with regulatory standards.
ManufacturingMarket ResearchMedicalMedical Device
Responsibilities
Collaborate with Senior Data Manager to manage clinical trial data collection, cleaning, and validation processes
Work with data management team to design, implement, and maintain data collection systems (e.g., electronic data capture (EDC))
Ensure that data is entered into EDC according to protocol and regulatory guidelines
Ensure proper tracking of queries and data discrepancies and support resolution
Ensure the accuracy and completeness of trial data before database lock
Perform preliminary data analysis to support interim or final clinical trial reporting
Assist in the creation of clinical trial reports, including tables, listings, and figures
Conduct exploratory analysis as needed to support clinical decisions
Ensure compliance with ICH-GCP, FDA regulations, and other applicable guidelines and standards
Work with Senior Data Manager to develop and review data management documentation, including Data Management Plans (DMPs), Data Validation Plans, and Case Report Forms (CRFs)
Work with Senior Data Manager to provide regular updates on data status, issues, and progress to internal project teams
Communicate with clinical operations team to assess data quality and resolve any data-related issues or concerns
Troubleshoot and provide technical support for data-related issues encountered during the trial
Proactively identify data-related risks and work with stakeholders to mitigate these risks
Ensure proper documentation and tracking of data discrepancies or issues
Qualification
Required
Bachelor's degree in Life Sciences, Health Sciences, Statistics, Computer Science, or related field
2+ years of experience in clinical data management, clinical trial data analysis, or related field within the pharmaceutical, biotechnology, or CRO industry
Hands-on experience with EDC systems (e.g., MedNet, Medidata, Veeva Vault), data validation tools, and statistical software (e.g., Python, JMP, SAS, R)
Familiarity with clinical trial design and regulatory requirements (FDA, EMA, ICH-GCP)
Experience with data visualization tools such as Power BI
Strong analytical and problem-solving skills
Excellent communication skills (both verbal and written)
Ability to collaborate with cross-functional teams and stakeholders
Strong attention to detail and ability to work under tight deadlines
Preferred
CDISC (Clinical Data Interchange Standards Consortium) or equivalent certifications are a plus
Benefits
Medical, Dental, and Vision Insurance
Health Reimbursement Account (HRA)
Flexible Spending (FSA) / Dependent Care Accounts (DCA)
Short and Long-Term Disability
Group Term Life Insurance
401(k) with Safe Harbor Match
Unlimited PTO
13 Paid Holidays
Company
MDC Associates, Inc.
For over three decades, MDC has been the expert CRO partner for diagnostic innovators bringing critical tests to market.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Joen T. Johansen
President & CEO
Company data provided by crunchbase