The Bristol-Myers Squibb Company, doing business as Bristol Myers Squibb, is an American multinational pharmaceutical company. Headquartered in Princeton, New Jersey, BMS is one of the world’s largest pharmaceutical companies and consistently ranks on the Fortune 500 list of the largest U.S. corporations.

OneTrust Analyst & Developer II

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.

 

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: careers.bms.com/working-with-us.

 

 

Functional and Technical

• Proficiency in coding languages such as Java, JavaScript, Python, or C#
• Experienced in configuring and working with various industry leading data and privacy tools like OneTrust.
• Experience with web technologies like HTML, CSS, and JavaScript frameworks.
• Familiarity with database management and SQL.
• Understanding of version control systems.
• Knowledge of software development life cycle (SDLC) and methodologies.
• Experienced in systems integration methodologies and workflow management.
• Collaborate with privacy analysts to understand requirements and translate them into technical solutions.
• Independent, self-starter that supports DRO staff in collaborative issue resolution and improvement.
• Preferred experience with working in a multi-cultural, multi-location and diverse environments.

 

• B.E./B.Tech. or equivalent in computer science, engineering, information technology.
• Recognized privacy certifications and experience preferred.
• Experience in OneTrust is a must.
• At least 2-4 years of software development (privacy tech preferred).
• Knows Java, JavaScript, Python, or C#, SQL, Excel (advanced techniques) and has worked with databases.
• Ability to make decisions that impact their own work & others and works under minimal supervision.
• Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth.
• Understanding factors contributing to the team’s overall success.
• Excellent English Oral and written communication skills including the ability to deliver clear and articulate presentations.
• Ability to use PowerPoint, Excel, Word, or other technologies to communicate complex topics to stakeholders, manage personal workload, and track projects and issues.

 

#HYDIT #LI-Hybrid

 

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 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 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/

 

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job Title – Global Trial Specialist

 

Position Summary /Objective

 

• Contributes to the operational execution of clinical studies and supports complex global trials as needed.
• Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.
• Drives process / system enhancements related to GTS responsibilities / deliverables and manage / comply with various quality or compliance systems
• Manages country planning, protocol level attributes and milestones/drivers in CTMS.
• Manages the development and/or collection of study level documentation, support GTM in ensuring eTMF accuracy and completion for all studies.
• Manages the global setup of study level non-clinical supplies.

 

Position Responsibilities

 

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:

Study/Project Planning, Conduct and Management

• Understands study level tools and plans.
• Provides support to the GTM along with the appropriate teams for response to country/regulatory and IRB/IEC.
• Provides operational input and participates in operational processes in support of the startup maintenance and close out of studies.
• Assist the GTM in driving study execution.
• Learns, observes and performs core GTS tasks and escalates appropriately.
• Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.
• Raises possible issues for potential escalation to the appropriate colleagues.
• Follows instructions, determines level of understanding and seeks clarification when needed.
• Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.
• Develops, updates, and submits Transfer of Obligations to Regulatory Authorities.
• Manages global vendor site lists and resolve issues related to global site lists.
• Manages study mail-groups/distributions and SharePoint/Study Directory updates.
• Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
• Identifies issues and risks, develops mitigations, and escalates appropriately.
• Participates in filing activities and any associated audits as applicable.

 

Degree Requirements

• BA/BS or Associate degrees in relevant discipline.

 

Experience Requirements

• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is a plus.
• Experience in Clinical Research or related work experience.
• Global experience is a plus.

 

Key Competency Requirements

Technical Competencies

• Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Basic understanding of project management desired.

Management Competencies

• Begin to network and foster relationships with key stakeholders across the study team.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
• Displays a willingness to challenge the status quo and take risks.
• Effective oral and written communication skills, ability to influence cross-functionally, demonstration of leadership capabilities.

 

 

 

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 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.

Manager, Informed Consent, Informed Consent Management

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.

 

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: careers.bms.com/working-with-us.

 

 

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Position Responsibilities:

• Central triage of all study, county, and site level language modifications.
• Review and process language modifications and engage with relevant stakeholders who manage key concept language per BMS SOPs. Manage escalations key stakeholders, as appropriate.
• Track and assign requests for language modifications, ethic committee or health authority queries related to IC or other supporting materials.
• Collaborate with cross-functional teams across BMS to ensure both patient safety and quality, and specimen and data compliance.
• Provide subject matter expertise related to informed consent and support the BMS IC process including during audits and inspections as needed.
• Identify and resolve complex consent issues.
• Liaise with Regional Country Operations to ensure adherence to local laws/regulations/requirements.
• Guide BMS and CRO teams on use of informed consent template materials.
• Use critical thinking to solve problems and exercise good judgment.
• A subset of team members hired into the Manager IC role may also:
  • review consent documents and interpret consent allowable uses and retention periods to maintain adherence to the collection, retention, and utilization of biospecimens and data in line with the informed consent signed by the subject.
  • execute informed consent processes for clinical trials pertaining to use of specimens and data and act as subject matter expert in patient informed consent and regulatory topics around biospecimens.
  • Serve as the point of contact for study-related inquiries from HAs/IRBs/ECs regarding biospecimen and biomarker objectives and negotiate related consent language.
• Travel expectations are minimal (<5% domestic).

Degree Requirements

Bachelor’s degree with a scientific- or technical-related discipline.

Experience Requirements

Minimum 5+ years’ experience in pharma/clinical drug development/scientific discipline

Key Competency Requirements

The incumbent should have proficient skills in each of the following areas:

• Experience in the biopharma industry in clinical trial operations, with direct experience working with informed consent documents required.
• Experience in clinical specimen management, biobanking/biorepositories, biomarker and/or genetics research is also desirable.
• Strong written and verbal communication, presentation and organizational skills required.
• Ability to operate in a complex matrix organization.
• Understanding of Good Clinical Practice (GCP) requirements.
• Excellent interpersonal, organizational, and oral and written communication skills.
• Ability to effectively handle multiple, simultaneous, and complex tasks and projects and establish priorities.
• Ability to manage multiple priorities and complex projects in a dynamic environment.
• Skilled in multi-tasking in a fast-paced environment.
• Proficiency with Microsoft Teams, Office 365 Applications, Labmatrix or consent tracking platform, clinical trial systems (CTMS, eTMF) and adaptable to available online tools and databases.

 

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 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.