eCOA Manager, Clinical Assessment Technologies Operations
Worldwide Clinical Trials - USA
Durham, NC
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us! What Clinical Assessment Technologies Department does at Worldwide Clinical Assessment Technologies (CAT) is a team of highly experienced clinicians and operations experts whose purpose is to improve clinical outcomes data by reducing data variability associated with lack of training, inconsistent approaches to scale administration and scoring, placebo response, and incorrect source. The members of CAT have extensive industry-related experience stemming from their time working on the site level for sponsors and other service providers. Additionally, the CAT team has conducted more than 75 international Phase I to Phase IV trials and has trained over 7,000 raters. What you will do
- Serve as main contact for the eCOA vendor, Sponsor, and Worldwide study team members
- Manage vendor deliverables and timelines, as they relate to study assessments
- Negotiate with eCOA vendor and sponsor regarding eCOA scope of work (SOW)
- Review and identify study trends and proactively work with eCOA vendor and study team to address study specific requirements
- Conduct risk assessments to study due to vendor deliverable delays, availability of materials, equipment, and translations and related concerns
- Communicate above risks to study team and Sponsor in a timely manner
- Identify and liaise with key study functional leads to support eCOA related processes, including but not limited to: CAT team, Project Management (PM), Clinical Operations, Data Management (DM), and Biostatistics
- Facilitate collaboration between eCOA processes and DM data transfer requirements, eCRF build, and related needs
- Facilitate collaboration between eCOA vendor mapping specifications and DM and Biostatistics
- Participate in budget discussions, including Work Order, Change Order, and related inputs
- Coordinate and obtain sponsor approval for all vendor related costs and document/plan versions
- Responsible for reviewing and communicating with vendor regarding system change control, closeout, and database lock activities
- Collaborate with Worldwide study team to manage eCOA study timelines
- Organize and maintain CAT project files, study mailboxes, documents, sharepoint/portal and designated folders
- Develop eCOA specific Launch slides with CAT counterparts
- Organize, arrange, and lead eCOA related meetings with vendor, including Kick Off Meetings, project build meetings, and maintenance meetings
- Liaise, review, and provide input to all eCOA plans and content
- Oversee and participate in User Acceptance Testing activities
- Protocol consultation specific to eCOA
- Responsible for eCOA requirements gathering
- Highly organized, detail- and service-oriented
- Excellent problem-solving skills
- Excellent project management skills
- Excellent planning, managing, monitoring, scheduling, and critiquing skills
- Excellent at meeting timelines consistently and being able to effectively work under pressure
- Continuously open to constructive, developmental feedback
- Strong writing and verbal communication skills in order to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Strong ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment
- Strong adherence to company policies and procedures
- Strong self-motivation skills
- Strong ability to work in teams
- Excellent proficiency in all MS-Office applications including Microsoft Word, Excel, Teams, Adobe, and PowerPoint
- Bachelor’s degree, in Life Science preferred
- Minimum two years of experience working in eCOA and clinical trials
- Minimum two years of experience in project management
- The individual must demonstrate a strong ability to lead, understand policies and procedures, financial and leadership principles, possesses excellent time management and project management skills and communicate effectively.
- Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials
- Knowledge of SOPs and ICH/GCP/regulatory guidelines
- Competency working with data and numbers
- Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business)
- The role may require travel domestically and internationally in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.
Posted 2025-09-25
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