Title: Clinical Systems Manager / CSAR (Clinical Systems & Analytical Reporting) Manager
Duration: 12 months
Location: Remote
Possible extension: Yes

 
Note: REMOTE ROLE - Pacific time zone ideal. Willingness to adapt to varying time zones (PST and IST overlap). Primarily remote, but local availability for occasional onsite visits may be helpful.
Master’s degree preferred; bachelor’s degree with significant technical experience is acceptable.
 
Top 3 Must-Have Skill Sets:

• SAS
• Python
• Tableau/Spotfire

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 (e.g., India-based IQVIA team).
• 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.

 
Basic Qualifications:

• Doctorate Degree or Master Degree and 3 years of clinical experience
  OR
• Bachelor 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

 
Red Flags:

• No Clinical Operations experience, No experience in Pharma. Candidates without relevant industry experience are not preferred.
• Short Job Tenures: Candidates with frequent job changes (less than 1-2 years) are seen as unreliable for long-term roles.
• Overqualification: PhD candidates are typically avoided due to potential for role mismatch or lack of long-term commitment.
• Insufficient Technical Expertise: Lack of hands-on SAS or Python experience.
• Inability to demonstrate independent thought or relying on external prompts during interviews.

 
Interview Process:
Video call:
1. Initial screening by the client for overall fit and red flags.
2. Technical interview with the team focusing on role-specific tasks.
Additional interviews if needed to confirm candidate suitability. 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $71.16/hr.