Clinical Data Management Associate II - US - Remote- San Antonio, TX

CDM Associate II

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 Clin Spark 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 Clin Spark, 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 Clin Spark 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 complete required training for the position
• 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 in processes and resolution
• 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 database management knowledge
• Excellent written and oral communication skills
• Comfortable presenting to internal and external stakeholders
• Exceptional attention to detail
• Knowledge of the clinical research…