Temp Clinical Outcome Assessment Manager

Tarrytown, NY, United States
Dec 19, 2020
Required Education
Bachelors Degree
Position Type
The Clinical Outcomes Assessment Manager (COM) is accountable for electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team. Other accountabilities include the eCOA project timelines, translation, eCOA study specifications, executing UAT, and ensuring collection of eCOA is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.

This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs). The balance of direct leadership versus oversight of eCOA will vary accordingly.

In this role a typical day might include:
  • Responsibility & accountability for the successful delivery of eCOA for one or more clinical research trials with quality and compliance
  • Responsibility for reviewing and approving project related eCOA study documentation during the Project Lifecycle
  • Providing input into protocol development as it relates to clinical outcomes
  • Participating in creation of eCOA standards
  • Supporting Clinical Study Lead with license acquisition
  • Responsibility for eCOA and translation vendor selection
  • Leading all aspects of eCOA vendor performance at the clinical trial level, including oversight of critical metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues.
  • Contributing to risk management planning and coordinating resolution & risk mitigation of all eCOA systems related issues and end of study vendor reports
  • Being responsible for communication planning, information distribution, performance reporting, and project closure.
  • Providing support for problem resolution between eCOA vendors and Regeneron study team
  • Supervising financial components related to COA and Innovation for each study
  • Collaborating with study team members on medical monitoring plan
  • Collaborating with data management on eCOA data specifications, standards, and transfers
  • Providing training and mentorship to new staff
  • Applying problem solving strategies to issues and maintaining issue tracking documentation supervise progress and ensure timely resolution to critical issues
  • Developing strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
  • Facilitating communication of clinical innovations in eSource modalities to partners and broader organization
  • Supporting strategy for implementation of innovative clinical trial technologies and ground-breaking innovations
  • Providing consultation on eCOA modality benefits, risks, costs and process
  • Facilitating and chipping in to study level lessons learned
  • Recommending and participating in cross-functional and departmental process improvement initiatives
  • May require up to 25% travel
This role may be for you if:
You have demonstrated knowledge of eCOA systems development processes
You have the ability to understand and implement the strategic direction and guidance for respective clinical studies
You have a data driven approach to planning, executing, and problem solving
You can perform and handle multiple tasks at one time to meet deadlines in a sophisticated environment working
You are a multifaceted leader who can influence and negotiate at all levels internally and externally
You have a depth of experience managing external vendors
You are an effective project manager with cross-functional team leadership and organizational skills

To be considered, you must have a Bachelor's degree at least 3 years of relevant experience. Knowledge of ICH/GCP and regulatory guidelines is also vital for success in the role. You will also need to have shown technical proficiency in trial management systems and Microsoft Project Server.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.