Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client is mission is to discover and deliver innovative medicines and solutions that address complex health issues and enhance people's lives.
Job Title: Clinical Data Systems Designer II
Location: North Chicago, IL/Irvine, CA
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client is mission is to discover and deliver innovative medicines and solutions that address complex health issues and enhance people's lives.
Job Title: Clinical Data Systems Designer II
Location: North Chicago, IL/Irvine, CA
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job Description:
Purpose:
- The Clinical Data Systems Designer II supports the delivery of clinical trial data systems, external vendor data acquisition, and fit-for-purpose datasets for reporting, analysis, and regulatory submissions.
- The role brings together people, processes, and technology to generate business value from clinical trial data.
- The position ensures that study protocol requirements are appropriately reflected in clinical system designs, external vendor data-acquisition requirements, system integrations, data aggregation, data transformation, and data quality controls.
- The role also supports the consistent use of common clinical data standards across studies, programs, and therapeutic areas.
Responsibilities:
- Leads external vendor data acquisition for multiple concurrent studies throughout the study lifecycle, from requirements definition and specification development through data delivery, issue resolution, reconciliation, and study closeout.
- Ensures that study protocol requirements are accurately reflected in clinical system designs, external data-acquisition requirements, and applicable clinical data standards, including CDISC, CDASH, and SDTM.
- Collaborates extensively with Data and Statistical Sciences, clinical study teams, data management, programming, technology teams, external vendors, and other cross-functional partners to achieve study and program objectives.
- Aggregates clinical trial data from multiple internal and external sources into centralized clinical data warehouses; supports data transformation, multisource reconciliation, quality controls, and delivery of SDTM and reporting-ready datasets.
- Accountable for the timely design and delivery of clinical systems, system integrations, and required system changes, including EDC and IRT, while using project-management tools to track study progress and plan work.
- Coordinates upstream and downstream dependencies, anticipates risks to timelines or data quality, and develops practical options and solutions to maintain delivery across assigned studies.
- Serves as a clinical data systems and technology point of contact, working with data and statistical colleagues and external vendors to troubleshoot data-acquisition, integration, reconciliation, and process-flow issues.
- Promotes therapeutic-area and program-level consistency in clinical system design, external vendor data acquisition, data standards, and data-processing approaches.
- Acts as a clinical data systems subject matter expert during regulatory inspections and internal quality audits and ensures adherence to applicable regulations, GCP, ICH guidelines, SOPs, and functional quality standards.
- Coaches and mentors Data Science Associates and contributes to cross-functional innovation, standardization, and continuous process-improvement initiatives.
Qualifications:
- Bachelor's degree in business, management information systems, computer science, life sciences, or an equivalent field; master's degree preferred.
- At least 3 years of clinical technology experience involving systems such as EDC, IRT, or ePRO; or at least 5 years of experience in a similar technical or clinical development role.
- Demonstrated knowledge of clinical research, the clinical trial process, and the full study lifecycle.
- Working knowledge of CDISC standards, including CDASH and SDTM.
- Demonstrated SAS and/or SQL programming skills and knowledge of database concepts.
- Experience with clinical system design, integrations, clinical data warehouses, multisource data aggregation, data transformation, data reconciliation, and standardized or reporting-ready clinical datasets preferred.
- Experience leading external vendor data acquisition across multiple concurrent studies throughout the study lifecycle, including the development of third-party data acquisition specifications.
- Demonstrated analytical, troubleshooting, and problem-solving skills.
- Demonstrated effective written and verbal communication skills and the ability to influence others without direct authority.
- Demonstrated ability to collaborate extensively across functions, influence without direct authority, manage upstream and downstream dependencies, and support process improvement and technology innovation initiatives.
Key Stakeholders:
- Data and Statistical Sciences teams
- Clinical study and program teams
- Clinical technology and systems teams
- Data management and programming functions
- Cross-functional partners supporting clinical development
Top 3-5 skills, experience or education required for this position:
- Working experiences and knowledge with external vendor data
- 3+ years of clinical technology experience with EDC, IRT, ePRO, or related platforms
- Clinical data warehouse and multisource data aggregation and reconciliation experiences
- Clinical research and CDISC knowledge.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | North Chicago, IL |
| Industry | Computer/IT Services |
| Salary | $70–$78 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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