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

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 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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you bring to the role

• 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)

Your experience

• Bachelor’s degree

• 1–3 years of data management experience

• Familiarity with medical terminology

• 1–3 years of clinical research experience preferred

• 1–3 years of general quality control experience preferred

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.