Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.Job ResponsibilitiesThe eCOA Manager is responsible for the end-to-end planning, implementation, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions across assigned clinical trials. This role acts as the primary point of accountability for eCOA delivery, ensuring systems are configured, validated, deployed, and maintained ulatory standards, and sponsor expectations.The eCOA Manager partners closely with Clinical Operations, Data Management, Biostatistics, vendors, and sponsors to deliver high quality, patient centric electronic assessment solutions that support protocol objectives, data integrity, and study timelines.Key Tasks:Lead eCOA delivery activities from startup through clos-out, including requirements gathering, system build, UAT script writing, UAT conduct, ongoing maintenance, etcDevelop and manage eCOA project plans, timelines, and risk mitigation strategies in alignment with study milestonesServe as primary eCOA subject matter expert for assigned studies, providing guidance, implementing lessons learned and best practicesMaue resolution, timelines, etcCollaborate with internal stakeholders (i.e., clinical, DM, biostats, etc.) and sponsorLead/support sponsor communications, participation in governance meetings and provision of status updates through the life of the studyOversee eCOA system build, including questionnaires (also knows as scales, assessments or instruments), visit schedules, languages, devices, etc.Key Competencies:Subject matter expertise in eCOA technologies and patient reported outcomesStrong project and vendor management skillsExcellent communication and stakeholder engagement abilitiesHigh attention to detail with a quality focused mindsetAbility to proactively identify risks and drive solutionsTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained hereluding the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.comAdditional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained hereluding the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
10 days ago