About Company
GlaxoSmithKline (GSK) is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. We are committed to helping people do more, feel better, and live longer. With a rich history of innovation, GSK is at the forefront of developing groundbreaking medicines, vaccines, and specialty products to address some of the world’s most pressing health challenges. Our diverse portfolio and robust pipeline reflect our dedication to scientific excellence and patient well-being. We foster an inclusive culture where every individual is valued, and their contributions drive our collective success. Joining GSK means becoming part of a team that is passionate about making a real difference in global health, guided by our core values of patient focus, transparency, respect, and integrity. We are continuously striving to push the boundaries of medical research and deliver life-changing solutions to communities worldwide.
Job Description
We are urgently seeking a highly meticulous and dedicated Clinical Data Coordinator to join our innovative team in Wellen Park, North Port. In this critical role, you will be instrumental in the successful execution of clinical trials by ensuring the integrity, quality, and completeness of clinical data. As a Clinical Data Coordinator at GSK, you will play a pivotal part in the journey from clinical trial initiation to regulatory submission, directly contributing to the development of new treatments and therapies that improve patient lives globally. Your day-to-day responsibilities will involve comprehensive data review, query generation and resolution, and database lock preparation in adherence to regulatory standards (e.g., FDA, ICH-GCP). You will collaborate closely with clinical project managers, clinical research associates, biostatisticians, and other cross-functional teams to maintain impeccable data quality throughout the trial lifecycle. This position requires a keen eye for detail, a strong understanding of clinical trial processes, and proficiency in various clinical data management systems. You will be expected to identify data trends, discrepancies, and potential issues, escalating them appropriately and proactively working towards resolution. This is an exciting opportunity for a motivated professional to make a significant impact within a leading global biopharma company, contributing to research that truly matters. If you are passionate about clinical research and possess a commitment to data excellence, we encourage you to apply and help us get ahead of disease together.
Key Responsibilities
- Perform comprehensive data review and validation activities to ensure accuracy, consistency, and completeness of clinical trial data.
- Generate, track, and resolve data queries with investigative sites and clinical monitoring teams in a timely manner.
- Assist in the development and review of clinical trial documentation, including Case Report Forms (CRFs), data management plans, and data validation specifications.
- Participate in user acceptance testing (UAT) for Electronic Data Capture (EDC) systems and other clinical databases.
- Support the preparation for database lock activities, ensuring all data is clean and ready for analysis.
- Collaborate with internal and external stakeholders, including clinical operations, biostatistics, medical writing, and regulatory affairs.
- Ensure adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and relevant regulatory guidelines.
- Contribute to the continuous improvement of data management processes and standards.
- Provide regular status updates on data management activities to project teams.
Required Skills
- Bachelor's degree in Life Sciences, Healthcare, or a related field
- Minimum 2 years of experience in clinical data management or clinical research
- Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical)
- Strong understanding of clinical trial processes, ICH-GCP guidelines, and regulatory requirements (e.g., FDA 21 CFR Part 11)
- Excellent attention to detail and strong analytical skills
- Effective communication and interpersonal skills
- Ability to work independently and as part of a collaborative team
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Preferred Qualifications
- Master's degree in a relevant scientific or health-related discipline
- Experience with medical coding (MedDRA, WHODrug)
- Familiarity with SAS or other statistical software packages
- Certification in Clinical Data Management (e.g., CCDM)
Perks & Benefits
- Competitive salary and performance-based bonuses
- Comprehensive health, dental, and vision insurance plans
- 401(k) retirement savings plan with company match
- Generous paid time off, including holidays and vacation
- Employee assistance program and wellness initiatives
- Opportunities for professional development and career growth
- Tuition reimbursement program
- Employee stock purchase plan
- Work-life balance initiatives
- On-site fitness center (where applicable) and employee discounts
How to Apply
To apply for this exciting and urgent opportunity, please click on the application link below. Ensure your resume and cover letter highlight your relevant experience and qualifications for the Clinical Data Coordinator role. We look forward to reviewing your application and potentially welcoming you to the GSK team.