Clinical Outcomes Assessment Operations Consultant

GForce Life Sciences; New Jersey; Remote; USD 110,000 - 165,000; Full time

Job summary

GForce Life Sciences is seeking a Clinical Outcome Assessment (COA) Operations and Patient Experience Study Management Consultant for a 12-month remote contract.

You will plan, implement, and execute patient-focused data collection across clinical programs, ensuring compliance and alignment with timelines.

Qualifications

• Bachelor's degree in a relevant field required.
• 5+ years supporting COAs in clinical trials.
• Experience with eCOA implementation and electronic systems.
• Demonstrated vendor/CRO/eClinical partner experience.
• Strong project management and organizational skills.
• Excellent written and verbal communication; able to work independently across functions.

Responsibilities

• Oversee operational delivery of COA and patient experience initiatives across trials.
• Coordinate implementation of patient-reported, clinician-reported, observer-reported measures.
• Ensure licensing, translation, validation, training and modality adjustments.
• Lead in-trial patient interview activities and related procedures.
• Manage eCOA platform implementations and embedded workflows.
• Monitor changes, COA data surveillance, and vendor relationships.
• Track timelines, budgets, and quality expectations.

Skills

Project management

Vendor management

COA knowledge

eCOA systems

Communication skills

Education

Bachelor's degree in Public Health, Epidemiology, Outcomes Research, Health Services Research, Life Sciences, Psychology, or related field

Tools

eCOA platforms

UAT

Job description

Clinical Outcome Assessment (COA) Operations & Patient Experience Study Management Consultant

Duration: 12- month Contract

Location: Remote

Position Summary

We are seeking an experienced Clinical Outcome Assessment (COA) Operations and Patient Experience Study Management Consultant to support the planning, implementation, and execution of patient-focused data collection activities across clinical development programs. This individual will oversee the operational delivery of Clinical Outcome Assessments (COAs) and patient experience initiatives within clinical trials, ensuring high-quality execution, regulatory compliance, and alignment with study timelines.

The ideal candidate brings a strong understanding of COA implementation, eCOA systems, vendor oversight, and cross-functional collaboration within pharmaceutical, biotechnology, CRO, or eClinical environments.

Key Responsibilities

COA Operations & Implementation

• Support the execution of Clinical Outcome Assessment strategies across assigned clinical studies and development programs.
• Coordinate implementation of patient-reported, clinician-reported, observer-reported, and performance outcome measures within clinical trials.
• Ensure timely completion of COA licensing, translation, linguistic validation, modality adjustments, and rater training activities.
• Lead operational implementation of in-trial patient interview activities and related study procedures.

eCOA & System Management

• Facilitate implementation and maintenance of electronic Clinical Outcome Assessment (eCOA) platforms.
• Partner with internal and external stakeholders to configure systems and embedded workflows.
• Lead User Acceptance Testing (UAT) activities and support issue resolution prior to study launch.
• Monitor change control activities and support ongoing COA data surveillance processes.
• Manage relationships with external vendors and service providers supporting COA activities.
• Track project timelines, deliverables, budgets, and quality expectations.
• Identify and elevate risks while driving solutions to maintain study milestones.
• Coordinate multiple projects simultaneously while ensuring successful execution.

Study Support & Evidence Generation

• Support activities related to the development and validation of COA measures using qualitative and quantitative methodologies.
• Contribute to literature reviews, interview studies, survey research, and psychometric evaluation efforts as needed.
• Partner with cross-functional stakeholders to execute patient experience initiatives that support clinical endpoint strategies.
• Serve as a key point of contact for COA-related operational activities.
• Collaborate with Clinical Operations, Data Management, Biostatistics, Regulatory, Procurement, and external partners.
• Communicate project updates, timelines, and study outcomes to internal teams and leadership.

Quality & Compliance

• Ensure all activities comply with applicable regulations, guidance documents, and organizational procedures.
• Support inspection and audit readiness activities and assist with remediation efforts when necessary.
• Maintain documentation and records in accordance with quality standards and Good Clinical Practice (GCP).

Qualifications

Required

• Bachelor's degree in Public Health, Epidemiology, Outcomes Research, Health Services Research, Life Sciences, Psychology, or a related field.
• Minimum of 5 years of experience supporting Clinical Outcome Assessments (COAs) within clinical trials.
• Experience managing eCOA implementation and electronic clinical systems.
• Demonstrated experience working with vendors, CROs, or eClinical partners.
• Strong project management and organizational skills.
• Excellent written and verbal communication skills with the ability to work independently and collaboratively across functions.
• Knowledge of clinical development processes, regulatory expectations, and patient-focused data collection practices.

Preferred

• Master's degree in a relevant discipline.
• Experience within pharmaceutical, biotechnology, CRO, or eCOA vendor environments.
• Familiarity with qualitative research methods, targeted literature reviews, and psychometric validation activities.
• Experience supporting therapeutic area programs in areas such as neuroscience, immunology, nephrology, or other specialty indications.