eCOA Operations Specialist

Location
Princeton, NJ, United States
Posted
Sep 25, 2020
Ref
R1530295
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities involve a combination of execution and oversight, dependent.

on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:
  • Drives licensing with Global Outsourcing Manager, submission and retrieval of COAs from the COAM (Clinical Outcomes Assessment Management) library.
  • Partners with cross-functional team members to ensure the initial eCOA study design, study build and deployment of devices across trials.
  • Manages the eCOA implementation timeline.
  • Acts as central point of contact for communication between the team and eCOA vendor on matters concerning translation availability and IRB/EC submission timelines. Escalates issues related to vendors as necessary.
  • External review of eCOA-related CRO activities.
  • Review of external eCOA-related activities: checks paper and eCOA deployment of instruments for accuracy and escalate issues to eCOA vendors.
  • Accountable for stakeholder communications/change management and resolution/mitigation of issues and risks (escalate as appropriate).
  • Contributes to internal/external continuous improvement initiatives/teams. (e.g., representation on eCOA SuperUser Network/COAM team).
  • Drive process/system enhancements related to eCOA Specialist responsibilities/deliverables.
  • Manage and comply with various quality and compliance systems
  • Supports the study training needs related to eCOA instruments and management


Degree Requirements

Bachelor's degree required.

Experience Requirements

1-3 years of pharmaceutical, biotech, data/information technology experience preferably in the area of clinical trial, clinical outcome assessment, data, or technology management
  • Project Management and planning skills, preferred
  • Knowledge of GCP/ICH guidelines, regulations and BMS procedures/policies
  • Ability to analyze and interpret complex issues and propose solutions
  • Experience with team collaborations and driving innovation
  • Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings


Key Competency Requirements

Effective oral and written communication skills, ability to influence cross-functionally, demonstration of leadership capabilities.

Travel Required

Minimal

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.