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

Worldwide Clinical Trials•San Antonio, TX

2d•$63,000 - $125,000•Onsite

About The Position

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.

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

Nice To Haves

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.

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.