Clinical Data Management Associate II - US - Remote- San Antonio, TX
Worldwide Clinical TrialsAbout the role
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the CDM Associate II does at Worldwide
The Clinical Data Management Supervisor is responsible for eSource database design and development, electronic case report form (eCRF) design, and the monitoring, management, and archival of clinical data for all trials conducted at Worldwide Clinical Trials Early Phase Services Phase I Unit. The primary role is to troubleshoot for the clinic and other areas of the Clinical Pharmacology Unit (CPU), as well as to present ClinSpark to potential new clients. This role also serves as a liaison between the Data Management team and the Clinical Data Management team. A secondary responsibility is to assist other Clinical Data Management Associates in study building. This position has direct reports and reports to the Site Director.
What you will do
• Manage ClinSpark, an off-the-shelf electronic source system for Phase I clinical research
• Design study databases to ensure accurate creation of eSource and eCRFs for data collection
• Adhere to International Council for Harmonization - Good Clinical Practice (ICH-GCP) guidelines and Clinical Data Interchange Standards Consortium (CDISC) standards
• Export clinical data listings and completed eCRFs to vendors as required
• Assist with and perform database lock and unlock procedures
• Review study protocols and supporting documents for each study
• Attend study initiation visits and study planning meetings regularly
• Develop eSource databases for capturing clinical data and manage required mid-study updates
• Identify appropriate transfer fields for development of case report forms
• Assist in tracking and driving departmental timelines and milestones
• Prepare documents for final study report inclusion and assist in managing identified discrepancies
• Create eCRF completion guidelines and access instructions for each study
• Develop study-specific Data Management Plans as required
• Create database specifications documents and perform verification/acceptance testing of configured databases
• Perform medication and medical history coding as required
• Review, examine, and perform manual and automated quality checks of data to identify discrepancies and resolve data integrity issues
• Provide support and training for staff utilizing the eSource system
• Provide support and training for monitors and sponsor representatives utilizing the eSource system
• Manage archival of clinical trial documents, including paper and electronic records
• Liaise with internal and external data management or biostatistics teams
• Manage the data collection library
• Participate in system upgrades and validation testing as required
• Identify areas for process improvement and provide recommendations to management
• Present ClinSpark capabilities to potential new clients in conjunction with staff during bid defense meetings and to support business development efforts
• Maintain professionalism in behavior, appearance, and customer service when interacting with sponsors and internal staff as a representative of Worldwide Clinical Trials
• Demonstrate strong collaboration with Worldwide Clinical Trials staff regarding data and compliance issues
• Represent Worldwide Clinical Trials in a professional manner (verbal, written, and appearance) when interacting with sponsors, volunteers, vendors, and employees
• Plan and manage daily workload to meet established study timelines
• Coordinate with clinical staff to communicate priorities and maintain efficient workflow
• Request, schedule, and
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