Clinical Systems Manager
Spectraforce
Newbury Park, California
3 days ago
Job Description
Job Title: Clinical Systems Manager
Location: Remote
Duration: 1 year
100% Remote, preferably Pacific Time (but Eastern is acceptable)
Duration: 1-year contract, extendable by 6 months
Summary:
The ideal candidate will have at least 8 years of experience as a Clinical Programmer or Study Designer supporting global clinical trials, with strong proficiency in Medidata Rave for study design, edit check programming, and metadata configuration. They should possess a Bachelor’s degree or higher and have worked in collaboration with Functional Service Providers (FSPs), preferably IQVIA, acting as a liaison between data management teams and offshore programming teams. The candidate must be technically skilled, able to interpret and translate study requirements from Protocol Leads (PLs) and Lead Data Managers (LDMs), and ensure quality and timely delivery of database builds and updates. Experience in big pharma environments (e.g., Pfizer, Gilead) and exposure to Veeva EDC or automation tools is a plus. The role is fully remote, with a preference for candidates in the Pacific Time Zone. Strong communication skills, a collaborative mindset, and the ability to work independently in a fast-paced setting are essential. Overqualified candidates or those lacking clinical EDC experience will not be considered. see red flags.
Summary of Key Responsibilities
Preferred Qualifications
Basic Qualifications
Red Flags:
Interview Process:
Virtual interview/s ( Video call )
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
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: $64.04/hr.
Location: Remote
Duration: 1 year
100% Remote, preferably Pacific Time (but Eastern is acceptable)
Duration: 1-year contract, extendable by 6 months
Summary:
The ideal candidate will have at least 8 years of experience as a Clinical Programmer or Study Designer supporting global clinical trials, with strong proficiency in Medidata Rave for study design, edit check programming, and metadata configuration. They should possess a Bachelor’s degree or higher and have worked in collaboration with Functional Service Providers (FSPs), preferably IQVIA, acting as a liaison between data management teams and offshore programming teams. The candidate must be technically skilled, able to interpret and translate study requirements from Protocol Leads (PLs) and Lead Data Managers (LDMs), and ensure quality and timely delivery of database builds and updates. Experience in big pharma environments (e.g., Pfizer, Gilead) and exposure to Veeva EDC or automation tools is a plus. The role is fully remote, with a preference for candidates in the Pacific Time Zone. Strong communication skills, a collaborative mindset, and the ability to work independently in a fast-paced setting are essential. Overqualified candidates or those lacking clinical EDC experience will not be considered. see red flags.
Summary of Key Responsibilities
- Accountable for quality delivery and ensuring team competencies within the service area
- Lead study-level system requirements meetings with vendors and internal stakeholders
- Assist in designing and developing study-specific technical documentation
- Support internal teams in managing project timelines and associated activities
- Collaborate with Data Management (DM) to define data transfer requirements
- Work with external partners to manage user acceptance test (UAT) creation and execution
- Identify, track, and resolve study-related technical issues
- Contribute to continuous process and quality improvement initiatives
- Study Design & Edit check Programming in Medidata RAVE
- Coordinate and work with FSP( Functional Service Provider) team
- Coordinating and providing programming support to Clinical Study Teams
Preferred Qualifications
- Bachelor’s degree in Life Sciences, Computer Science, Engineering, Business, or related field
- 4+ years of experience in clinical development
- Hands-on experience with clinical systems such as CTMS, EDC, IVRS, ePRO, or similar technologies in the pharmaceutical/biotechnology industry
- Strong knowledge of Good Clinical Practices (GCP) and relevant FDA regulations
- Demonstrated project management and technical expertise
- High attention to detail with strong documentation and communication skills
- PMP certification (preferred)
- Prior vendor management experience
- Excellent time management and organizational abilities
- Strong problem-solving, judgment, and decision-making skills
- Ability to thrive in a team-based environment with minimal supervision
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:
- Overqualified Candidates (e.g., 15+ years of experience without clear relevance or motivation)
- Irrelevant Experience (candidates lacking clinical or EDC system experience)
- Not Familiar with Medidata Rave (must be proficient)
Interview Process:
Virtual interview/s ( Video call )
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
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: $64.04/hr.