Senior Remote Clinical Data Entry Specialist – Expert in EDC, SDV, and Patient Safety for brighthush

About brighthush

brighthush is a trailblazer at the intersection of clinical research and digital innovation. With a global presence that spans continents and a team of over 1,200 dedicated professionals, we are reshaping how therapeutic breakthroughs are discovered, validated, and delivered to patients worldwide. Our core philosophy centers on data integrity, regulatory excellence, and patient‑centricity. By harnessing next‑generation electronic data capture (EDC) platforms, artificial intelligence‑driven validation tools, and a culture of continuous learning, we empower researchers to focus on what matters most: improving lives.

Why Join brighthush?

When you become part of brighthush, you’re not just filling a role—you’re stepping into a mission that directly influences the future of medicine. Here’s what makes us stand out:

• Fully Remote, Flexible Hours – Work from anywhere, on a schedule that respects your personal commitments.
• Competitive Compensation & Performance Bonuses – Earn a salary that reflects your expertise, with additional rewards tied to data quality and project success.
• Comprehensive Health Coverage – Inclusive medical, dental, vision, and telehealth plans for you and your family.
• Unlimited Paid Time Off & Generous Parental Leave – Prioritize well‑being without sacrificing career momentum.
• Professional Growth Ecosystem – Access to industry‑leading courses, certifications, conferences, and a mentorship program that accelerates your career trajectory.
• Recognition & Feedback Culture – Monthly shout‑outs, peer awards, and transparent performance discussions keep you motivated and celebrated.
• State‑of‑the‑Art Tools – Work with cutting‑edge EDC platforms, AI‑based data validation, and collaborative dashboards that streamline your workflow.

Role Overview

We are seeking an Experienced Remote Data Entry Specialist to join our Clinical Research Operations team. In this pivotal role, you will be the guardian of data quality for our clinical trials, ensuring that every patient record is accurate, complete, and compliant with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. You will collaborate closely with investigators, coordinators, and data managers to resolve queries, perform source data verification, and maintain the integrity of our electronic database.

Key Responsibilities

• Review and process research charts for accuracy, completeness, and adherence to study protocols.
• Complete Electronic Data Capture (EDC) tasks efficiently, ensuring timely entry of patient information.
• Perform rigorous quality control of EDC entries, identifying and correcting discrepancies.
• Conduct Source Data Verification (SDV) by cross‑checking paper and electronic records.
• Gather data from multiple source documents and enter it into the designated electronic database system.
• Address data queries and implement necessary corrections to maintain data integrity.
• Resolve complex queries by retrieving information from the research team and assessing for completeness and accuracy.
• Conduct safety calls with patients enrolled in studies, ensuring they receive timely support and accurate information.
• Escort patients to and from exam rooms, ensuring they are attended to and in the right place at the right time.
• Collaborate with cross‑functional teams to meet data entry and cleaning timelines.
• Maintain confidentiality and security of sensitive patient information in compliance with HIPAA and other regulatory standards.
• Stay current with ICH GCP best practices, guidelines, and regulatory updates.
• Participate in occasional travel (less than 2 weeks per year) to support on‑site data verification and training sessions.

Essential Qualifications

• High school diploma or equivalent; associate’s or bachelor’s degree in a related field preferred.
• Minimum of 2 years of experience in data entry, clinical data management, or a related role.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook) and experience learning new software quickly.
• Strong understanding of clinical trial processes, including data capture, source data verification, and query resolution.
• Excellent attention to detail, with a proven track record of producing error‑free work.
• Strong analytical and critical thinking skills, with the ability to troubleshoot data issues independently.
• Excellent verbal and written communication skills, capable of conveying complex information clearly.
• Ability to work independently in a remote setting, managing time effectively and meeting deadlines.
• Physical ability to sit for prolonged periods, lift up to 15 pounds, and perform repetitive typing tasks.

Preferred Qualifications

• Experience with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle Clinical, or similar platforms.
• Knowledge of ICH GCP guidelines and regulatory requirements for clinical research.
• Experience in patient safety call handling and patient engagement activities.
• Familiarity with data validation tools and statistical software (e.g., SAS, R).
• Previous experience in a clinical research organization (CRO) or pharmaceutical company.
• Certification in Clinical Data Management or related field.

Skills & Competencies

• Data Integrity & Quality Assurance
• Source Data Verification (SDV)
• Electronic Data Capture (EDC) Proficiency
• Query Management & Resolution
• Regulatory Compliance (ICH GCP, HIPAA)
• Patient Communication & Safety Call Handling
• Problem‑Solving & Analytical Thinking
• Time Management & Prioritization
• Team Collaboration & Cross‑Functional Coordination
• Adaptability & Continuous Learning

Career Growth & Learning Opportunities

At brighthush, your career trajectory is supported by a robust learning ecosystem:

• Structured mentorship programs pairing you with senior data managers.
• Access to industry‑leading training modules on clinical data management, regulatory compliance, and emerging technologies.
• Opportunities to lead data quality initiatives, project management, or process improvement projects.
• Clear promotion pathways from Data Entry Specialist to Senior Data Analyst, Data Manager, or Clinical Data Lead.
• Annual performance reviews with transparent career planning discussions.

Work Environment & Culture

brighthush fosters a culture of innovation, inclusivity, and empowerment. Our remote teams thrive on:

• Open communication channels: weekly virtual stand‑ups, monthly town halls, and an internal Slack workspace.
• Recognition of achievements through peer‑to‑peer shout‑outs and quarterly awards.
• Encouragement of work‑life balance with flexible scheduling and mental health resources.
• Commitment to diversity, equity, and inclusion, with employee resource groups and inclusive hiring practices.
• Regular hackathons and idea‑sharing sessions to drive process improvements.

Compensation & Benefits

While specific numbers may vary based on experience and location, brighthush offers:

• Competitive base salary aligned with industry standards for remote data entry specialists.
• Performance‑based bonuses tied to data quality metrics and project milestones.
• Full health, dental, and vision coverage, including telehealth options.
• 401(k) plan with company match.
• Unlimited paid time off, sick leave, and paid parental leave.
• Professional development stipend for courses, certifications, and conferences.
• Access to wellness programs, mental health counseling, and an employee assistance program.

How to Apply

Ready to make a difference in clinical research? Submit your resume and a brief cover letter highlighting your data management experience and why you’re excited to join brighthush. We look forward to exploring how your skills can help us deliver high‑quality data that drives breakthrough therapies.