Digital Architect

9 months ago

Mumbai Maharashtra, India Bristol-Myers Squibb Full time

**Working with Us**
Challenging. 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.

**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**
- 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.

**Degree Requirements**

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.
- 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

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a div

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