eCOA Operations Specialist
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.
The eCOA Operations Specialist will work across all therapeutic areas and research phases to collaborate with cross-functional global teams to execute on assigned operational aspects of complex global clinical research studies related to Clinical Outcomes Assessments.
In collaboration with the Global Trial Manager (GTM) and other stakeholders, the eCOA Ops Specialist is responsible for the initiation and oversight of COA licensing, ensures availability of finalized master versions, translations and delivery to study teams and/or eCOA vendor in paper or electronic format.
Accountable for accuracy and resolution of COA translation process issues and COA deployment via Electronic Clinical Outcome Assessments (eCOA) through management of eCOA vendor and outsourcing relationships.
Ensures effective alignment of COA processes with other business processes and regulatory requirements for inspection readiness.
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
Bachelor’s degree required.
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
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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