About the Role
Our client, a progressive clinical research organization (CRO), is seeking a highly organized and technically adept Farmacéutico de Investigación Clínica y Gestión de Datos to join their remote team. This role is integral to the successful execution of clinical trials, focusing on the meticulous management and integrity of clinical data. The ideal candidate will have a strong background in pharmaceutical sciences, combined with expertise in clinical data management systems and practices. You will be responsible for ensuring that clinical trial data is accurate, complete, and compliant with regulatory standards (GCP). This position offers an excellent opportunity to work on diverse clinical studies across various therapeutic areas, contributing to the development of new medicines from the comfort of your home office. Our client is committed to fostering a culture of scientific rigor, collaboration, and operational excellence in a remote-first environment. Join a dedicated team that is passionate about advancing medical research and improving patient outcomes worldwide.
Key Responsibilities
- Manage and oversee the collection, cleaning, and validation of clinical data from clinical trials.
- Develop and maintain Case Report Forms (CRFs) and electronic data capture (EDC) systems.
- Ensure data accuracy, completeness, and consistency in accordance with study protocols and GCP guidelines.
- Perform data reviews and identify data discrepancies, working with clinical sites and study teams to resolve them.
- Generate data management reports, including status updates and quality metrics.
- Contribute to the development of Data Management Plans (DMPs).
- Collaborate with statisticians, programmers, and clinical operations teams to ensure seamless data flow and analysis.
- Ensure compliance with data privacy regulations (e.g., GDPR, HIPAA) and company SOPs.
- Participate in the validation of EDC systems and other data management tools.
- Stay current with industry best practices and technological advancements in clinical data management.
Requirements
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Nursing, or a related health science field.
- Minimum of 3-5 years of experience in clinical data management or clinical research coordination, with a strong understanding of pharmaceutical drug development.
- Proficiency in using electronic data capture (EDC) systems and clinical data management software.
- Thorough knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements for clinical trials.
- Strong understanding of clinical trial processes and data flow.
- Excellent analytical and problem-solving skills with meticulous attention to detail.
- Proficiency in data validation, cleaning, and query management.
- Excellent written and verbal communication skills in Spanish and English.
- Ability to work independently and manage multiple projects effectively in a remote setting.
- Proficiency in Microsoft Office Suite, particularly Excel.
Benefits
- Competitive salary and potential for performance-based incentives.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan.
- Generous paid time off and holidays.
- Opportunities for professional development, training, and certification in data management.
- Flexible remote work environment with support for home office setup.
- Opportunity to work on global clinical trials and contribute to life-changing therapies.
- Collaborative and supportive team culture.
- Access to advanced data management technologies.
- Career growth opportunities within a leading CRO.