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Clinical Systems Manager

Remote:

Full Remote

Experience:

Expert & Leadership (>10 years)

Work from:

United States

Offer summary

Qualifications:

Doctorate degree or Master’s with 3 years of experience, Bachelor’s with 5 years of experience, Associate degree with 10 years of experience, High school diploma with 12 years of experience.

Key responsabilities:

Manage SAS Edit Check and Clinical Data Reporting
Ensure accountability for patient data reporting services

ICONMA Human Resources, Staffing & Recruiting Large https://www.iconma.com/

1001 - 5000 Employees

See more ICONMA offers

Job description

Clinical Systems Manager

Location: Remote
Duration: 12 months with possible extension

Description:
The Clinical Systems & Analytical Reporting (CSAR) Manager (CW) will function as the Operations Manager for the Patient Data Reporting Team, overseeing the SAS Edit Check, SAS Clinical Data Reporting, and Spotfire operations. The Patient Data Reporting Team Operations Manager will be responsible for managing system-related tasks associated with the SAS Edit Check, SAS Clinical Data Reporting, and Spotfire, as well as supporting patient data reporting requirements for both EDC and non-EDC data types. The Operational Manager will be accountable for ensuring service delivery oversight and process compliance with support from Functional Service Providers (FSPs). Moreover, the Operational Manager will contribute to data management efforts involving patient data reporting needs of various new clinical sources. Also, as a critical process expert, will represent Patient Data Reporting team in key transformation projects, functional governance groups, and cross-functional systems integrations. Collaborate with other CSAR Managers and cross-functional teams to identify opportunities for developing business cases, driving operational efficiencies, enhancing effectiveness, and improving delivery cycle time and quality. The demands of this role include but are not limited to supporting technical changes, identifying process improvements, and improving applications to mitigate risks and minimize impact.

Job Responsibilities (include but are not limited to):
Serve as the Operations Manager for the SAS Edit Check, SAS Clinical Data Reporting, and Spotfire operational areas within the CSAR System Study Services & Programming group.
Ensure overall accountability for Patient Data Reporting services by providing quality oversight to meet study timelines, ensuring metrics and performance align with established timeframes and quality expectations.
Promote innovation by advocating for automation and adoption of advanced technologies to streamline services.
Act as the point of contact for continuous improvement initiatives focusing on data mapping, data handling, and data quality.
Demonstrate a thorough understanding of business processes to identify system efficiencies and support processes that enhance efficiency, quality, and compliance.
Serve as a subject matter expert to offer technical expertise and business process support to FSP for patient data issues and development activities, assist in audit preparations and responses to audit findings (internal or external), and ensure adherence to data governance policies, standards, and principles.
Develop robust integrations and data collection strategies for CTDB and non-EDC external vendor/partner generated clinical trial data, test and deploy business-critical automation solutions, promote consistency across programs and therapeutic areas (TA), and drive continuous improvement initiatives to identify system and process efficiencies, thus ensuring continued data quality.

Basic Qualifications:
Doctorate Degree OR master’s degree and 3 years of Clinical experience OR bachelor’s degree and 5 years of Clinical experience OR Associate degree and 10 years of Clinical experience OR High school diploma/GED and 12 years of Clinical experience

Top 3 Must Have Skill Sets:
SAS, Python, Tableau/Spotfire,

Red Flags:
No Clinical Operations experience, No experience in Pharma