Senior Clinical Trial Data Entry & Patient Safety Support Specialist – Driving Data Accuracy, Safety Call Mastery, and Regulatory Excellence in Global Clinical Studies

About brighthush and the Clinical Research Landscape

brighthush stands at the forefront of clinical research, partnering with leading pharmaceutical, biotechnology, and medical device innovators to translate groundbreaking science into life‑saving therapies. With a global footprint that spans North America, Europe, and Asia, brighthush is celebrated for its unwavering commitment to scientific rigor, patient safety, and operational excellence. Our teams thrive on curiosity, collaboration, and a relentless pursuit of quality—values that are embedded in every phase of the clinical trial lifecycle.

In the fast‑evolving world of clinical research, data integrity and patient safety are non‑negotiable. The role of a Clinical Trial Data Entry & Patient Safety Support Specialist is pivotal in ensuring that every data point is accurate, every safety signal is captured, and every patient interaction is handled with the utmost professionalism. If you are passionate about data, meticulous in your work, and eager to contribute to life‑changing medical advancements, brighthush offers you a platform to make a real impact.

The Role: A Strategic Pillar in Clinical Excellence

As a Senior Clinical Trial Data Entry & Patient Safety Support Specialist, you will serve as the linchpin that connects raw clinical data to actionable insights. Your expertise will safeguard the integrity of study datasets, while your patient‑centric approach will ensure that safety signals are identified, documented, and escalated in a timely manner. You will collaborate with investigators, data managers, and safety teams across multiple sites, driving consistency and compliance across the entire study portfolio.

Key Responsibilities

• Data Capture & Validation – Accurately enter patient data into electronic data capture (EDC) systems, ensuring completeness, consistency, and adherence to study protocols.
• Source Document Review – Scrutinize source documents, case report forms (CRFs), and medical records to verify data accuracy and resolve discrepancies.
• Safety Call Management – Conduct timely patient safety calls, document adverse events (AEs), and coordinate with clinical teams to ensure prompt reporting and follow‑up.
• Data Quality Assurance – Perform regular data audits, query generation, and resolution to maintain high data quality standards.
• Regulatory Compliance – Adhere to Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and local regulatory requirements.
• Collaboration & Communication – Work closely with investigators, site coordinators, data managers, and safety teams to resolve issues and streamline processes.
• Documentation & Reporting – Prepare detailed reports on data entry metrics, safety call outcomes, and quality improvement initiatives.
• Continuous Improvement – Identify bottlenecks in data workflows and propose solutions to enhance efficiency and accuracy.

Essential Qualifications

• High school diploma or equivalent; bachelor’s degree in Life Sciences, Nursing, or a related field preferred.
• Minimum of 2 years’ experience in clinical data entry, patient safety, or a related clinical research role.
• Proficient with EDC platforms (e.g., Medidata Rave, Oracle Clinical) and Microsoft Office Suite.
• Strong analytical and critical‑thinking skills with a keen eye for detail.
• Excellent verbal and written communication abilities.
• Ability to multitask, prioritize, and meet tight deadlines in a dynamic environment.
• Knowledge of GCP, ICH guidelines, and regulatory reporting standards.
• Experience with adverse event reporting and safety database management is a plus.

Preferred Qualifications

• Advanced degree (Master’s or PhD) in a life science discipline.
• Prior exposure to multi‑site, multi‑phase clinical trials.
• Familiarity with data cleaning tools such as SAS or R.
• Experience in a CRO or clinical research organization (CRO) setting.
• Multilingual capabilities to support international study sites.

Core Skills & Competencies

• Data Integrity – Commitment to maintaining the highest standards of data accuracy and completeness.
• Patient‑Centric Mindset – Empathy and professionalism when interacting with study participants.
• Problem‑Solving – Ability to identify root causes of data discrepancies and implement effective solutions.
• Team Collaboration – Strong interpersonal skills to work seamlessly across multidisciplinary teams.
• Adaptability – Flexibility to adjust to changing study protocols, timelines, and priorities.
• Technical Proficiency – Comfortable navigating complex software systems and troubleshooting technical issues.
• Time Management – Efficiently juggle multiple tasks while maintaining quality and accuracy.

Career Growth & Learning Opportunities

At brighthush, we believe that professional development is a shared journey. As a Senior Clinical Trial Data Entry & Patient Safety Support Specialist, you will:

• Gain exposure to a diverse portfolio of therapeutic areas, from oncology to neurology.
• Participate in cross‑functional training sessions covering advanced data management, pharmacovigilance, and regulatory affairs.
• Earn certifications such as Certified Clinical Research Professional (CCRP) or Certified Clinical Data Manager (CCDM) through our tuition reimbursement program.
• Progress into roles such as Data Manager, Safety Officer, or Clinical Project Lead, depending on your interests and performance.
• Engage in mentorship programs pairing you with seasoned professionals who can guide your career trajectory.

Work Environment & Company Culture

brighthush fosters an inclusive, collaborative, and innovative workplace. Our culture is built on:

• Integrity – Upholding ethical standards in every decision and action.
• Innovation – Encouraging creative problem‑solving and continuous improvement.
• Respect – Valuing diverse perspectives and fostering a supportive community.
• Work‑Life Balance – Offering flexible scheduling, remote work options, and wellness programs.
• Recognition – Celebrating achievements through awards, shout‑outs, and career milestones.

Compensation, Perks, and Benefits

While specific figures may vary based on location and experience, brighthush offers a competitive salary package complemented by:

• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Paid time off, including vacation, sick leave, and holidays.
• Professional development stipend and tuition reimbursement.
• Employee wellness initiatives such as gym memberships, mental health resources, and mindfulness sessions.
• Annual company retreats and team‑building events.
• Access to cutting‑edge technology and tools to streamline your workflow.

Why Join brighthush?

When you join brighthush, you become part of a mission‑driven organization that places patient safety and data excellence at the forefront of clinical research. You’ll work alongside passionate scientists, clinicians, and data experts who are dedicated to transforming patient care worldwide. Your meticulous data entry and safety support will directly influence the success of groundbreaking therapies, ensuring that patients receive the safest and most effective treatments available.

We value curiosity, resilience, and a commitment to quality—qualities that define our team and our impact. If you are ready to take your career to the next level, contribute to life‑changing research, and thrive in a culture that rewards innovation and integrity, we invite you to apply today.

Ready to Apply?

Take the next step in your career by submitting your application through our online portal. We look forward to discovering how your expertise and passion can help brighthush continue to set the standard for clinical research excellence.

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