Clinical Data Associate Jobs in Texas (NOW HIRING)

What the CDM Associate II does at Worldwide

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 ClinSpark 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 ClinSpark, 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 ClinSpark 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 process, including Good Clinical Practice

Your experience

Bachelor's degree with at least three to five years of data management experience
Familiarity with medical terminology
Previous supervisory experience managing small or large teams
Prior customer-facing experience required
Preferred: One to three years of clinical research experience
Preferred: Three to five years of supervisory experience
Preferred: One to three years of general quality control experience
Data management certification and/or previous ClinSpark study design 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.