Clinical Data Management Supervisor - US - ONSITE - San Antonio, TX

Worldwide Clinical Trials • San Antonio, TX

11h • Onsite

About The Position

Worldwide Clinical Trials is a global, midsize CRO that focuses on innovation and pioneering approaches to find cures for diseases. They are seeking individuals who are passionate about improving lives and value this pursuit. The company emphasizes a supportive and inclusive environment where professionals from diverse backgrounds can succeed and thrive. The Clinical Data Management Associate III role is responsible for managing ClinSpark, an electronic source system for Phase 1 clinical research. This involves designing study databases, ensuring accurate eSource and eCRF creation, and adhering to ICH-GCP and CDISC standards. The position supports data integrity through quality checks, database management, and collaboration with stakeholders. The associate also interacts with Sponsors and internal staff, requiring strong communication and customer service skills. Key responsibilities include planning workload, coordinating with clinical staff, supporting training, and contributing to business development by presenting ClinSpark capabilities.

Requirements

• Strong ability to troubleshoot issues, identify errors, and assist or train others on processes and resolutions
• Self-motivated with the ability to manage multiple tasks and deadlines in a fast-paced environment
• Strong sense of urgency and ability to balance priorities and meet deadlines
• Strong computer skills, including knowledge of database management
• Excellent written and oral communication skills with the ability to present to internal and external clients
• Exceptional attention to detail
• Knowledge of the clinical research process, including Good Clinical Practice (GCP)
• Bachelor’s degree
• 1–3 years of data management experience
• Familiarity with medical terminology

Nice To Haves

• 1–3 years of clinical research experience preferred
• 1–3 years of general quality control experience preferred

Responsibilities

• 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 interactions with Sponsors, volunteers, vendors, and employees
• Plan and manage daily workload to meet study timelines and priorities
• Coordinate with clinical staff to communicate priorities and maintain workflow efficiency
• Request, schedule, and complete required training for the role
• Perform other duties as assigned.

Benefits

• Competitive benefits package depending on location

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level