Clinical Trial Registration Specialist

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. 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 Registration Sr. Specialist

Division

Research & Development

Functional Area Description

Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM) / CT Transparency & Submission

Position Summary / Objective

The Clinical Trial Registration Sr. Specialist will report to the Clinical Trial Registration Lead, prepare and provide operational support for the registration and maintenance of clinical trials into public registries in US, EU and other countries as required.

Position Responsibilities

Drives the processes for assigned protocol registration activities, resulting in timely, high-quality information posted on clinical trial registries (Clinicaltrials.gov and EU PAS).

Liaises with clinical team reviewers (Global Trial Managers, Operations Leads, Statisticians, Clinical Trial Physicians, Clinical Scientists, Development Leads, Patent Attorneys) and other stakeholders on all assigned trials to ensure trial registrations are accurate, consistent with the protocol and other source data, and reported in adherence to NIH guidelines.

Provides maintenance support to CT Registration Lead for assigned records, to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov.

Submits registration updates to Clinicaltrials.gov on behalf of clinical team, within global regulatory timelines.

Maintains study trackers and ensures they are up to date every week.

Educates stakeholders, as needed, on NIH detailed review criteria for registrations as well as on the purpose and format of the different fields in the protocol registration form.

Support registration of clinical trials in public registries beyond US / EU as needed.

Degree Requirements

Bachelor's degree, preferably in a Science-related field

Experience Requirements

Minimum of 3 years overall work experience, preferably in a biopharmaceutical or CRO company

Work experience in quality, regulatory, compliance, clinical research or drug development highly desirable

Work experience in clinical trial transparency or clinical trial execution work, or work experience related to quality and compliance in clinical research preferred

Key Competency Requirements

Demonstrated Excel and analytical skills

Ability to work in a multi-functional team and across multiple therapeutic areas

Demonstrated ability to work independently and seek out support when needed''

Written and oral communication skills''

Strong organizational skills with the ability to multitask and prioritize, and take on new initiatives and improvement efforts.

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

Responsibilities

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 [HIDDEN TEXT] . 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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Skills Required

Analytical Skills, Clinical Research, drug development, Excel