When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking a Clinical Data Management Associate with 2+ years of experience to support clinical trial data review, data cleaning, query management, and vendor data reconciliation activities. The role involves reviewing clinical data listings, resolving data discrepancies, performing CRF freeze and lock activities, coordinating with internal and external stakeholders, conducting User Acceptance Testing (UAT), and maintaining study documentation within Veeva Vault/eTMF. The ideal candidate will have hands-on experience with EDC systems, clinical data review tools, and a strong understanding of clinical research data management processes.
Clinical Data Review and Data Cleaning
Clinical Data Listings Review
Query Management and Discrepancy Resolution
Vendor Data Reconciliation, including Local Lab Review
External Data Review and Reconciliation
CRF Freeze and Lock Activities
User Acceptance Testing (UAT) for Listings, Screens, and Edit Checks
eTMF Documentation and Veeva Vault Management
Clinical Data Workbench Experience
Knowledge of Clinical Trial Data Management Processes
Understanding of ICH-GCP, Regulatory Guidelines, and 21 CFR Part 11
Cross-functional Collaboration and Stakeholder Management
Strong Written and Verbal Communication Skills
EDC: Medidata RAVE (Preferred), Oracle Clinical
Data Review: J-Review, Spotfire
Documentation: Veeva Vault, eTMF
Microsoft Office Suite, Microsoft Project, PowerPoint
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline.
Minimum 2+ years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment.
Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical.
Experience in data review, query management, vendor reconciliation, and database lock activities.
Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes.
Experience with Veeva Vault and eTMF documentation is preferred.
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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