Tarrytown, NJ or Basking Ridge, NJ
- Responsible & accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance
- Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle
- Applies eCOA systems expertise on day-to-day activities when issues are escalated
- Communicates with internal and external stakeholders and escalates risks
- Provides input into protocol development as it relates to clinical outcomes
- May participate in creation of eCOA standards
- Define and support strategy for eCOA migration and COA validation
- Support Clinical Study Lead with license acquisition
- Responsible for eCOA and translation vendor selection, in collaboration with study team
- Oversee eCOA vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues.
- Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to COA: Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all eCOA systems related issues and end of study vendor deliverables, Risk management planning, Communication planning, information distribution, performance reporting, and project closure.
- Provides support for problem resolution between eCOA vendors and study team
- Monitor financial components related to COA and Innovation for each study
- Collaborate with study team members on medical monitoring plan
- Collaborate with data management on eCOA data specifications, standards, and transfers
- Provides training and mentor new staff
- Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
- Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
- Communicates clinical innovations in eSource modalities to stakeholders and broader organization
- Develops strategy for implementation of innovative clinical trial technologies and disruptive innovations
- Provide consultation on eCOA modality benefits, risks, costs and process
- Facilitates and contributes to study level lessons learned
- Recommends and participates in cross-functional and departmental process improvement initiatives
- Responsible for direct supervision of staff
- Clinical Operations Experience (Clinical Research Associate or Clinical Trial Management Experience
- Bachelor Degree
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The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.