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.
The Clinical Data Management Associate will support the Data Management Lead (DML) in the planning, setup, execution, monitoring, and closeout of clinical studies. The role is responsible for database build activities, data review, vendor oversight, study documentation, quality management, and ensuring high-quality clinical data delivery in compliance with regulatory requirements, SOPs, and study timelines.
Key Skills & Experience
6+ years of End-to-end Clinical Data Management experience from protocol review, CRF/eCRF design through database lock.
Strong experience in EDC systems: Medidata RAVE and Oracle Clinical.
Expertise in Data Review, Query Management, Query Trend Analysis, Protocol Deviation Review, and Data Quality oversight.
Experience authoring and reviewing DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines, and related study documents.
Knowledge of FDA/ICH-GCP guidelines, clinical drug development process, and regulatory submission requirements.
Experience overseeing CRO/CDM vendors and managing study deliverables within timelines.
Strong project management, metrics reporting, and stakeholder management skills.
Experience supporting audits, inspections, and cross-functional study teams.
Excellent communication, mentoring, and leadership abilities.
Key Responsibilities
Support DML in study planning, execution, and project management activities.
Draft EDC build timelines and perform database/edit check specification activities.
Conduct UAT/testing for database, coding, site payment, and safety integrations.
Create and maintain study documents and ensure filing in eTMF per study requirements.
Coordinate data review activities and vendor deliverables.
Support Data Quality Review meetings and provide study metrics.
Manage post-production, migration, and database lock activities.
Ensure high-quality, timely study delivery in compliance with SOPs and regulatory requirements.
Provide training and mentoring to junior Clinical Data Management staff.
Location Hyderabad, Office Based
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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