Job Title: Clinical Systems Manager
Duration: 12 months
Location: Remote (candidates across the U.S.)
Possible Extension: Yes

Top 3 Must-have skills:

• Able to understand and digest protocol information associated with eCOA.
• eCOA Issue Management.
• eCOA Specification writing/review/advise.

Ideal Candidate: 

• The ideal eCOA Technical Specialist will have 3 years of experience with eCOA vendors (e.g., Clario, Signant Health, Medidata, Clinical Ink) and a solid understanding of eCOA technical specifications, timelines, and governance processes. 
• They should be proven to manage projects, troubleshoot issues, and advise on translation and licensing processes. 
• Strong project management skills are essential, including managing timelines, vendor relationships, and escalations. 
• The candidate must also excel in collaboration and communication, guiding global clinical trial managers on best practices, and documenting processes in systems like Merit. 
• A positive, team-oriented personality, adaptability to remote work, and professionalism in cross-functional settings are critical. While a bachelor’s degree is preferred, hands-on eCOA experience is prioritized over formal education. 
• Candidates with steady employment histories (2-3 years per role) are preferred.

Key Responsibilities Include:

• Accountable for quality delivery and competencies within the eCOA service area.
• Oversee study-level system requirements meetings with eCOA vendors and internal stakeholders.
• Assist in the design and development of study-specific technical documents.
• Support the internal team in managing project-related timelines and associated activities.
• Partner with data management (DM) to define the requirements for data transfers.
• Work with external resources to manage the creation and execution of user acceptance tests.
• Identify and track study-related technical issues to resolution.
• Provide a supportive framework for continuous process and quality improvements.

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

Preferred Qualifications:

• Bachelor’s Degree in life science, computer science, engineering, business, or related discipline.
• 4+ years of experience in clinical development.
• Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO, or other related technology in the pharmaceutical/biotechnology industry.
• Knowledgeable in Good Clinical Practices, and FDA regulations necessary.
• Project management and technical expertise, attention to detail, and excellent documentation and communication skills.
• PMP
• Previous vendor management experience.
• Excellent time management and organization skills.
• Have sound problem resolution, judgment, and decision-making abilities.
• Be able to work well in a team-based environment with minimal supervision.
• Someone with previous WFH experience.

Red Flags: Short period of work in between roles. Only Data management experience.
 

 

 

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.