- Management of clinical trial activities within digital platforms during study start up and execution.
- Provides digitization assistance to Clinical Study Team during Protocol Concept and Protocol development.
- Drives (with the protocol team) the authorization of protocol time and event sections for new BMS studies and Amendments
- Matrix manages specific clinical team roles for completion of the study start up activities related to data management, sample management, vendor selections, and other various clinical operations.
- Acts as a Project Manager, drives and owns operational timelines related to the digitization of clinical trials.
- Assists the development of the Case Report Form/database build.
- Assists with the standardization of controlled terms in digital platforms.
- Reviews the protocol to identify study design for the purpose of digitizing elements of the protocol. Remains critical to the protocol development and review process to ensure the most efficient data collection strategy is implemented.
- Functions as the primary contact with BMS clinical staff for SOAP assistance
- Communicates and resolves digital platform issues with Clinical Study Teams and all stakeholders as appropriate.
Digital Architect - Field, India - Bristol Myers Squibb
Description
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: .
Job Title
Digital Architect - Manager
Division
Research and Development / Global Development Operations /
Trial Delivery Support / Study Optimization and Assessment Planning (SOAP)
Functional Area Description
Trial Delivery Support is a core GDO team responsible for supporting study startup for clinical study teams along providing support with analytics to development and study level teams for the purpose of trial optimization.
Position Summary / Objective
The Digital Architect role will be at the center of a dynamic technology model with various BMS data platforms. The role will be a leader interested in the digitization of clinical trial designs, protocols, and other elements required for a Clinical Study Team. These efforts and work within data platforms will support advanced analytics, trial optimization, artificial intelligence, and document accelerations. The Digital Architect is a valued influencer of BMS technologies, systems, and digitization efforts required for our BMS clinical trials.
Position Responsibilities
Bachelor's Degree required - B.S./B.A. degree in Life Sciences or equivalent is preferred
Experience Requirements
At minimum three years of clinical trials, programming or regulatory experience in a pharma research or central clinical lab organization
Key Competency Requirements
• Comprehensive understanding of clinical trial synopsis development (not a lead for decision making) and protocol development within early development and full/late development
• Ability to promote the right usage of standards for Processes, Applications, and controlled terminology standardizations within digital platforms
• Collaborative mindset to enable partnerships with clinical roles for the purpose of the digitization of the DCS (design concept sheet) and protocol document
• Comprehensive understanding of clinical trial operations, including PK, PD and Laboratory Safety testing terminology.
• Skillset to help facilitate and manage stage gates for a digital clinical trial within an application for synopsis development, new protocols, and protocol amendments
• Strong communicator with ability to manage communication across multiple cross functional groups (Clinical Study Teams, Vendors, and Analytics groups.
• Ability to proactively identify issues, make decisions, and resolve across cross functional teams
• Management of a digital clinical trial to help enable a digital data flow connectivity to other digital systems
• Ability to facilitate digital reports intended for clinical and operational roles
• Demonstrates good stakeholder management
• Understands how the issues of a single study can impact the overall project.
• Demonstrates a strong understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project.
• Ability to engages the clinical team to assist in the resolution of more complex issues.
• Experience in stakeholder management and conducting trainings for study teams and across other functional organizations
Travel Required
Limited
Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment
None
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 scienceTM , 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 an inclusive culture, promoting diversity 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 a diverse 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 . Visit 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.
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