Clinical Data Management Supervisor - US - ONSITE - 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 Clinical Data Management Associate does at worldwide
The Clinical Data Management Associate III manages ClinSpark, an off-the-shelf electronic source system for Phase 1 clinical research. This role is responsible for designing study databases, ensuring accurate creation of electronic source (eSource) and case report forms (eCRF), and adhering to International Council for Harmonization - Good Clinical Practice (ICH-GCP) guidelines and Clinical Data Interchange Standards Consortium (CDISC) standards. The position supports data integrity through quality checks, database management activities, and collaboration with internal and external stakeholders. The associate regularly interacts with Sponsors and internal staff, requiring professionalism, strong communication skills, and customer service excellence. They are responsible for planning and managing daily workload to meet study timelines, coordinating with clinical staff to maintain efficient workflows, and supporting training and system adoption. Additionally, this role contributes to business development efforts by presenting ClinSpark capabilities during bid defense meetings.
What you will do
Manage ClinSpark, an off-the-shelf electronic source system for Phase 1 clinical research
Design study databases to ensure accurate creation of eSource and case report forms (eCRF) 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 clinical data capture and manage required mid-study updates
Identify appropriate transfer fields for case report form development
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 per study
Create study-specific Data Management Plans as required
Create Database Specifications documents
Perform verification and 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 data collection libraries
Participate in system upgrades and validation testing as required
Identify areas for process improvement and provide information to management
Present ClinSpark capabilities to potential clients during bid defense meetings and support business development efforts
Represent Worldwide Clinical Trials professionally in verbal, written, and visual interaction
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