Clinical Data Management Associate – Remote Opportunity
Summary:
Veeda Lifesciences is seeking a highly motivated and experienced Clinical Data Management Associate to join our dynamic team. This is a remote position offering an excellent opportunity to contribute to global Phase III/IV clinical trials, enhance your skills in leading EDC systems like RAVE, and advance your career within a leading Contract Research Organization (CRO). If you possess a strong understanding of clinical data management principles, hands-on experience with RAVE, and a commitment to data quality, we encourage you to apply.
About Veeda Lifesciences:
Veeda Lifesciences is a full-service CRO providing comprehensive solutions for pharmaceutical, biotechnology, and medical device companies. We are dedicated to delivering high-quality data and efficient clinical trial management, helping our clients bring innovative therapies to market. We foster a collaborative and supportive work environment, encouraging professional growth and development for all our employees.
Job Description:
As a Clinical Data Management Associate, you will play a vital role in ensuring the integrity and quality of clinical data throughout the lifecycle of our clinical trials. You will be responsible for a range of data management activities, from CRF design to data cleaning and reconciliation, contributing to the successful execution of Phase III/IV global studies.
Key Responsibilities:
- Develop annotated CRFs and contribute to eCRF setup using EDC systems, preferably Medidata RAVE.
- Proactively manage clinical queries, warnings, and resolve data discrepancies efficiently.
- Review SAS program outputs, listings, and generate targeted queries to address data inconsistencies.
- Process external data, ensuring accurate integration into the clinical database.
- Reconcile Serious Adverse Events (SAEs) to maintain data consistency and completeness.
- Perform clinical coding using standardized medical terminologies (MedDRA, WHO-DD, CTCAE, or Sponsor-specific).
- Support User Acceptance Testing (UAT) activities to validate system functionality and data accuracy.
- Review and contribute to the development and maintenance of coding libraries.
- Update clinical data within eCRF platforms (RAVE proficiency is highly preferred).
- Create and maintain eCRF guidelines and documentation to ensure consistent data capture.
- Actively contribute to project timelines, quality metrics, and resource planning to ensure efficient project execution.
- Present data management activities and progress to both internal and external teams.
- Ensure compliance with global regulatory requirements, Good Clinical Data Management Practices (GCDMP), and data protection guidelines.
Qualifications:
We are looking for a detail-oriented and results-driven individual with the following qualifications:
Education:
- Bachelor of Science (B.Sc) degree in Applied Sciences, Statistics, Biostatistics, Mathematics, Biology, Pharmacy, or another related Life/Health Sciences field.
Experience:
- 3-5 years of relevant experience in Clinical Data Management within a pharmaceutical, biotechnology, or CRO setting.
- Proven hands-on expertise with Medidata RAVE, including building, testing, and maintenance. Certified RAVE Builder is mandatory.
- Experience in managing data for Phase III/IV clinical studies.
- Exposure to manual data cleaning techniques, clinical coding processes, and SAE reconciliation procedures.
- Proficiency in Microsoft Excel and working knowledge of statistical programming languages such as SAS, Python, or R.
Preferred Skills:
- Strong understanding of Electronic Data Capture (EDC) systems, with a focus on Medidata RAVE.
- Comprehensive knowledge of clinical trial processes and the Clinical Data Management (CDM) lifecycle.
- Excellent communication (both written and verbal), documentation, and problem-solving skills.
- Demonstrated ability to manage multiple CDM tasks simultaneously and deliver high-quality outputs within tight deadlines.
- Ability to work independently and collaboratively within a team environment.
Benefits:
Veeda Lifesciences is committed to providing a competitive and rewarding work environment. Our benefits package typically includes:
- Remote Working Flexibility: Enjoy the benefits of working from the comfort of your own home.
- Competitive Salary Package: We offer a competitive salary commensurate with experience and qualifications.
- Opportunity to Work on Global Clinical Trials: Contribute to the development of innovative therapies by working on global clinical trials.
- Career Growth in a Top CRO: Advance your career within a leading and growing CRO.
- Skill Enhancement: Enhance your skills in RAVE, SAS, coding, and regulatory compliance through ongoing training and development opportunities.
How to Apply:
If you meet the qualifications and are interested in this exciting opportunity, please submit your updated CV to [email protected].
Please note that only certified RAVE Builders will be considered for this position.
We look forward to hearing from you!