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Clinical Systems & Analytical Reporting (CSAR) Manager
Job Description
*Depending on experience
Ideal Candidate:
Technical Skills: SAS Certification and Experience: Strong SAS programming expertise, as many critical checks and outputs are created in SAS. Proficiency in Python for automation and report generation. Pharma Domain Knowledge: Prior experience in pharmaceutical or clinical operations to understand business requirements. Analytical Skills: Ability to analyze, interpret, and provide quality oversight on data cleaning and review processes. Rave and Database Knowledge: Familiarity with the front-end (Rave) database builds and processes to understand the data flow and sources. Knowledge of automation tools and emerging AI/ML technologies to improve efficiency.
Soft Skills: Ability to lead operational tasks and manage remote teams. Strong ownership of responsibilities, including ensuring project timelines and quality. Effective communication with statisticians, programmers, and data management teams. Capability to troubleshoot and propose improvements during system operations.
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.
*CO/NYC candidates might not be considered
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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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