Sr. Clinical Data Specialist

Our small start-up client is adding a Senior Clinical Data Specialist to lead and execute clinical data management activities, ensuring high-quality, compliant data across global clinical trials. This role plays a critical part in data review, trend identification, and data integrity, particularly as studies approach key milestones, including interim analyses. The ideal candidate brings strong analytical capabilities, deep experience in clinical data review, and the ability to operate both independently and collaboratively within a fast-paced, startup environment.

This is an opportunity to join a growing organization at a pivotal stage, where your contributions to data quality, analysis, and decision-making will directly impact clinical trial outcomes and future regulatory milestones.

Your role with the company:

Clinical Data Management & Oversight

• Lead or contribute to the development and execution of Clinical Data Management (CDM) plans
• Design and develop Case Report Forms (CRFs) aligned with protocol requirements
• Define edit checks and data validation specifications within the clinical database
• Author and maintain eCRF completion guidelines and data review guidelines
• Perform user acceptance testing (UAT) to ensure accurate and efficient data collection

Data Review & Quality

• Conduct ongoing clinical data review (listings, reports, trend analysis) to ensure data integrity and quality
• Identify incomplete or inaccurate data; generate queries and drive resolution
• Escalate data issues and trends proactively to cross-functional stakeholders
• Lead data review and quality-focused meetings

Cross-Functional Collaboration

• Partner with Clinical Operations, Biostatistics, Field teams, and external stakeholders to ensure aligned data processes
• Provide support and guidance to site personnel and field teams regarding data entry and database use
• Collaborate with Finance on study site payment tracking and database-related processes

Systems & Reporting

• Contribute to database builds, updates, and report development (Clindex, Power BI)
• Test clinical system reports and features to support trial operations
• Maintain user access and conduct periodic security reviews

Leadership & Mentorship

• Mentor and support junior team members
• Develop training materials and provide system training as needed

Desired Profile:

• Bachelor’s degree in Life Sciences, Engineering, or a related field (or equivalent experience)
• Minimum 6 years of clinical data management experience (or Master’s with 4+ years)
• 5+ years of medical device clinical research experience (IDE and post-market preferred)
• Strong experience with electronic data capture (EDC) systems
• Experience with Clindex is highly desirable 
• Experience supporting global trials preferred
• Strong expertise in clinical data review, data integrity, and query management
• Working knowledge of ICH, GCP, CFR, ISO requirements, and CDM best practices
• Analytical mindset with the ability to identify trends and solve complex data issues
• Strong organizational skills and attention to detail
• Ability to operate independently in a fast-paced, startup environment
• Effective communication skills across cross-functional teams

Additional Details

• Currently supporting multiple global cardiovascular trials
• Upcoming interim analysis milestone (approx. 500 patients) expected in late summer
• Collaborative team environment, including internal biostatistics and external statistical partners