Are you a skilled Clinical Data Management professional with a passion for ensuring data accuracy and compliance in the pharmaceutical and biotech industries? Endpoint Data Analytics (EPDA) is excited to announce an opening for the position of Clinical Data Manager – Data Analyst-II. If you have 2-5 years of experience in clinical data management and a strong understanding of industry standards, this could be the perfect opportunity for you to grow your career with a dynamic and innovative team.
About EPDA
At EPDA, we specialize in delivering high-quality data analytics and clinical data management services to the pharmaceutical, biotech, and CRO sectors. Our mission is to support the development of life-saving therapies by ensuring the integrity, accuracy, and compliance of clinical trial data. We pride ourselves on fostering a collaborative and inclusive work environment where professionals can thrive and make a meaningful impact.
Job Description: Clinical Data Manager – Data Analyst-II
As a Data Analyst-II, you will play a critical role in managing and analyzing clinical trial data to support the development of innovative therapies. Your responsibilities will include:
- Designing, validating, and maintaining Case Report Forms (CRFs/eCRFs) in Electronic Data Capture (EDC) systems.
- Collaborating with cross-functional teams, including clinical, biostatistics, and regulatory departments, to ensure compliance with CDISC/CDASH/SDTM standards.
- Ensuring adherence to global regulatory requirements, including ICH-GCP, FDA, EMA, GDPR, and sponsor-specific guidelines.
- Utilizing hands-on experience with leading EDC systems such as Medidata Rave, Oracle InForm, and Veeva Vault.
- Applying proficiency in coding dictionaries like MedDRA and WHO-DD to ensure accurate data coding and reporting.
Key Requirements
To excel in this role, you should have:
- 2-5 years of experience in clinical data management within a CRO, pharmaceutical, or biotech company.
- Strong knowledge of CDISC/CDASH/SDTM standards and their application in clinical trials.
- Familiarity with regulatory guidelines, including ICH-GCP, FDA, EMA, and GDPR.
- Hands-on experience with EDC systems such as Medidata Rave, Oracle InForm, or Veeva Vault.
- Excellent communication and collaboration skills to work effectively with cross-functional teams.
Why Join EPDA?
- Career Growth: Be part of a growing organization that values innovation and professional development.
- Impactful Work: Contribute to the development of life-changing therapies by ensuring the accuracy and compliance of clinical trial data.
- Collaborative Environment: Work with a team of passionate professionals who are dedicated to making a difference in the pharmaceutical and biotech industries.
How to Apply
If you meet the qualifications and are excited about this opportunity, we encourage you to apply today! Visit our career page at hr@epda.in to submit your application.
