ADVANCED BIO-LOGIC SOLUTIONS
eCOA Technical Specialist
ADVANCED BIO-LOGIC SOLUTIONS, Thousand Oaks, California, United States, 91362
Location:
Remote – Thousand Oaks, CA
Employment Type:
Contingent Worker (Contract, W2)
Compensation:
Open Market Rate
Summary of the Role
Join a
big biopharma leader
as an eCOA Technical Specialist. You’ll manage study-level eCOA delivery across vendors (e.g., Clario, Signant Health, Medidata, Clinical Ink), drive requirements and governance, troubleshoot issues, and guide teams on translations/licensing and best practices. Success requires strong project management, vendor coordination, and clear documentation (e.g., in Merit).
Key Responsibilities
Own quality delivery within the eCOA service area and support continuous process/quality improvements
Lead/oversee system requirements meetings with eCOA vendors and internal stakeholders
Author/review study-specific technical specifications and related documents
Track timelines and associated activities; manage escalations with vendors
Partner with Data Management to define data transfer requirements
Coordinate and oversee UAT planning/execution with external resources
Identify, log, and drive resolution of study-related technical issues
Required Experience & Skills
3+ years eCOA project management
with recognized vendors (Clario, Signant, Medidata, Clinical Ink, etc.)
Experience with
eCOA governance/issue management
and
specification review/authoring ; exposure to
translation/licensing
processes
Strong PM skills: timeline ownership, vendor relationship management, risk/issue tracking, escalation management
Effective communicator and collaborator; able to guide global CTMs and document in systems like
Merit
Professional, adaptable, team-oriented; steady work history (2–3 years per role preferred)
Preferred Qualifications
Bachelor’s in life science, CS/engineering, business, or related (hands-on eCOA experience prioritized over formal education)
4+ years in clinical development; implementation experience with CTMS, EDC, IVRS/IRT, ePRO, or related tech
Working knowledge of
GCP
and FDA expectations;
PMP
a plus
Excellent documentation, time management, and organization; sound judgment and problem solving
Prior
vendor management
experience; thrives with minimal supervision
Top 3 Must Have Skills
eCOA project management (≥3 years)
eCOA governance / issue management
eCOA specification review/authoring + translation support
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
"This posting is for Contingent Worker, not an FTE"
Remote – Thousand Oaks, CA
Employment Type:
Contingent Worker (Contract, W2)
Compensation:
Open Market Rate
Summary of the Role
Join a
big biopharma leader
as an eCOA Technical Specialist. You’ll manage study-level eCOA delivery across vendors (e.g., Clario, Signant Health, Medidata, Clinical Ink), drive requirements and governance, troubleshoot issues, and guide teams on translations/licensing and best practices. Success requires strong project management, vendor coordination, and clear documentation (e.g., in Merit).
Key Responsibilities
Own quality delivery within the eCOA service area and support continuous process/quality improvements
Lead/oversee system requirements meetings with eCOA vendors and internal stakeholders
Author/review study-specific technical specifications and related documents
Track timelines and associated activities; manage escalations with vendors
Partner with Data Management to define data transfer requirements
Coordinate and oversee UAT planning/execution with external resources
Identify, log, and drive resolution of study-related technical issues
Required Experience & Skills
3+ years eCOA project management
with recognized vendors (Clario, Signant, Medidata, Clinical Ink, etc.)
Experience with
eCOA governance/issue management
and
specification review/authoring ; exposure to
translation/licensing
processes
Strong PM skills: timeline ownership, vendor relationship management, risk/issue tracking, escalation management
Effective communicator and collaborator; able to guide global CTMs and document in systems like
Merit
Professional, adaptable, team-oriented; steady work history (2–3 years per role preferred)
Preferred Qualifications
Bachelor’s in life science, CS/engineering, business, or related (hands-on eCOA experience prioritized over formal education)
4+ years in clinical development; implementation experience with CTMS, EDC, IVRS/IRT, ePRO, or related tech
Working knowledge of
GCP
and FDA expectations;
PMP
a plus
Excellent documentation, time management, and organization; sound judgment and problem solving
Prior
vendor management
experience; thrives with minimal supervision
Top 3 Must Have Skills
eCOA project management (≥3 years)
eCOA governance / issue management
eCOA specification review/authoring + translation support
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
"This posting is for Contingent Worker, not an FTE"