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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 .

Job Title:

• Clinical Trial Manager

Department:

• Regional Clinical Operations

Purpose/Objective: The Clinical Trial Manager is responsible for the oversight and delivery management of clinical trials at the country level, ensuring timely, budget-conscious, and high-quality execution from start-up to closure. This role serves as the primary point of contact for both internal and external stakeholders at the country level.

Key Responsibilities:

• Coordinate cross-functional teams within the country, acting as the main point of contact with the protocol manager and global study team members.

• Collaborate with internal roles in the country and manage the site feasibility process, including proposing and validating country study targets.

• Develop and implement a country-level patient recruitment strategy and risk mitigation plan, ensuring study enrollment targets and timelines are met.

• Lead problem-solving and resolution efforts, including risk management, issue resolution, and appropriate escalation.

• Assess and set up local vendors during the study start-up period.

• Participate in and prepare for Investigator Meetings.

• Ensure that data in Clinical Trial Management Systems is current and complete and that access to eDC and vendor systems is available for country and clinical trial site personnel.

• Validate study-related materials, including protocols, Informed Consent Forms (ICF), and patient materials.

• Prepare country-specific documents, such as global country-specific amendments.

• Prepare materials for Site Initiation Visits (SIVs).

• Verify and confirm eTMF completeness at the country and site levels with the local team.

• Review Site Monitoring visit reports, take action within specified timelines, and escalate issues as necessary, ensuring proper documentation.

• Coordinate database locks and query follow-up, ensuring adherence to timelines.

• Ensure inspection readiness for assigned trials within the country, providing support for Health Authority inspections and pre-inspection activities.

• Coordinate, develop, and implement Corrective Actions/Preventive Actions (CAPA) for country-level audit findings, driving review, implementation, and completion.

• Lead local study team meetings.

• Review and approve payments (based on GOA) and manage patient compensation claims, if applicable.

• Manage site relationships, including addressing CRO-related issues.

• May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs).

• May perform site closure activities, including post-closeout.

• May act as the point of contact for sites.

• May support the preparation and submission of documents to obtain approval from local Health Authorities, Ethics Committees, and other relevant bodies.

Senior Level Expectations:

• Engage with the Global Trial Manager, line management, and/or Head of Clinical Operations to assist in resolving complex issues locally and/or globally.

• Serve as a key resource for colleagues by providing guidance, leading training, and mentoring other team members through both informal and formal presentations.

• May be assigned as a Lead Clinical Trial Manager for a study locally, as determined by leadership.

The starting compensation for this job is a range from

$91,000 - $114,000 , plus incentive cash and stock

opportunities (based on eligibility).

The starting pay rate takes into account the characteristics of the job, such as the required skills and the location 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 our BMS

Career Site.

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 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/ (https://careers.bms.com/eeo-accessibility) 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.

Company: Bristol-Myers Squibb

Req Number: R1584328

Updated: 2024-09-17 04:22:41.419 UTC

Location: Field

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.