Job Opportunity: Senior Clinical Data Specialist at Fortrea, Bangalore
Summary:
Fortrea is seeking a highly motivated and experienced Senior Clinical Data Specialist to join our dynamic team in Bangalore. This is an excellent opportunity to contribute to global clinical trials, ensuring the integrity and quality of clinical data while working with cutting-edge technologies and adhering to the highest industry standards. If you possess a strong background in clinical data management, a thorough understanding of regulatory guidelines, and a passion for data quality, we encourage you to apply.
About Fortrea:
Fortrea is a leading global provider of clinical development and commercialization solutions to the life sciences industry. We partner with pharmaceutical, biotechnology, and medical device companies to advance their innovative therapies and improve patient outcomes. At Fortrea, we are committed to fostering a collaborative and inclusive work environment where our employees can thrive and make a meaningful impact.
Key Responsibilities:
As a Senior Clinical Data Specialist, you will play a vital role in ensuring the accuracy, completeness, and consistency of clinical trial data. Your responsibilities will include:
- Data Review and Validation: Perform comprehensive reviews of clinical trial data in accordance with Data Management Plans (DMPs), Standard Operating Procedures (SOPs), and global regulatory compliance standards (ICH-GCP).
- Query Management: Generate and resolve data queries to address inconsistencies, errors, and missing information, ensuring the creation of clean and reliable datasets.
- Data Diagnostics and Reconciliation: Execute data diagnostics, listings, reconciliation processes, and validation programs to identify and resolve data discrepancies.
- Aggregate Analysis: Conduct aggregate data analysis to identify potential safety trends, outliers, or data inconsistencies that may impact study results.
- Database Support: Contribute to database design, annotation, and the development of edit checks to ensure data quality and integrity from the outset.
- Documentation and Planning: Assist in the creation and maintenance of essential study documentation, including CRF/eCRF guidelines, DMPs, and Quality Management Plans.
- Quality Control: Perform quality control (QC) checks across various data management activities to verify adherence to established procedures and identify potential areas for improvement.
- Audit Support: Support internal and external audits by providing relevant documentation and addressing audit findings through Corrective and Preventive Action (CAPA) implementation.
- Training and Mentorship: Provide training and mentorship to junior team members on data management tools, processes, and industry best practices.
- Collaboration: Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, and medical writing, to ensure project timelines and key performance indicators (KPIs) are met.
Required Qualifications:
- Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, Biomedical Sciences, Pharmaceutical Sciences, or Biotechnology.
- 4-6 years of experience in Clinical Data Management.
- Hands-on experience with Electronic Data Capture (EDC) systems.
- Proven experience in eCRF review, query management, and data validation checks.
- Strong knowledge of clinical trial workflows, ICH-GCP guidelines, and CDISC standards.
Preferred Skills:
- Experience working with Fortrea systems and SOPs.
- 2+ years of direct Electronic Data Capture (EDC) experience (e.g., Medidata Rave, Oracle Clinical).
- Knowledge of medical terminology and a scientific background.
- Excellent communication and stakeholder collaboration skills.
Why Join Fortrea?
At Fortrea, we offer a challenging and rewarding career path with opportunities for professional growth and development. Joining our team provides you with:
- Exposure to Leading Technologies: Work with cutting-edge clinical research technologies and innovative data management solutions.
- Global Collaboration: Collaborate with diverse global teams and contribute to international clinical trials.
- Structured Growth: Benefit from structured training programs and opportunities for career advancement within Clinical Data Management.
- Comprehensive Benefits: Enjoy a competitive salary and a comprehensive benefits package.
- Work-Life Balance: Experience a supportive work environment with hybrid or office-based flexibility options (depending on role requirements).
- Impactful Work: Contribute to the advancement of medical research and the improvement of patient outcomes.
Benefits:
- Competitive salary
- Learning & development programs
- Hybrid or office-based flexibility
- Opportunity to work in global trials
To Apply:
If you are a highly motivated and experienced Clinical Data Specialist seeking a challenging and rewarding career opportunity, we encourage you to apply. Please submit your resume and cover letter.