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Position Summary The Manager, eCOA Management role is essential to the study level operationalization of the eCOA capability for BMS clinical trials and directly contributes to the BMS R&D pipeline.
This role reports to the Associate Director, eCOA Management within GDM and is a full-time, office-based position with flexibility to work from home up to 50% of the time.
Position Responsibilities
- Providing leadership for eCOA user acceptance test (UAT) planning and execution including test planning, script writing, test issue resolution, and test completion. May also support test execution as needed.
- Providing training on UAT processes and best practices and mentoring testing staff.
- Managing defect tracking and resolution, ensuring all issues are logged, tracked, and resolved in a timely manner.
- Regularly reviewing and improving UAT processes to enhance efficiency and effectiveness.
- Understanding eCOA design requirements through document review and design meetings.
- Ensuring compliance with regulatory requirements for software validation and documentation.
- Working on broader eCOA operationalization activities which may include supporting document reviews, monitoring timelines and decommissioning studies.
- Managing work assignments to ensure timely delivery.
- Identifying and resolving issues which may negatively impact delivery of work. Seeking support from leadership as needed.
- Following procedural documents when completing deliverables.
- Supporting actions related to Health Authority inspections and internal audits for assigned studies.
- Developing productive cross-functional working relationships with key stakeholders throughout BMS including collaboration with clinical operations, data management, and external vendors.
Requirements
- Bachelor's degree is required.
- At least 3 years of experience in UAT, including assessing system requirements, developing test plans and scripts, and managing defect resolution in a regulated environment, preferably in the context of clinical trials.
- At least 2 years' experience with using eCOA systems.
- Good understanding of drug development, eCOA and UAT processes.
- Solid experience with clinical trial solutions, specifically with eCOA instruments and with testing tracking systems (e.g., JIRA, HP ALM).
- Good understanding of GxP, 21 CFR Part 11, software validation and Systems Development Life Cycle (SDLC) principles.
- Good communication skills including technical writing proficiency to develop test plans, scripts and summaries.
- Demonstrated ability to self-start, solve problems, collaborate with stakeholders and be accountable for results.
The starting compensation for this job is a range from $102,540 - $124,200, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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