Job Information
Bristol Myers Squibb Clinical Trial Registration Senior Specialist in Princeton, New Jersey
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 .
Job Title: Clinical Trial Registration Sr. Specialist
Division: Research & Development
Functional Area Description: Global Development Operations / Trial Delivery Support (TDS) / TMF & Transparency / Clinical Trial Transparency & Disclosure (CTT&D)
Position Summary / Objective: The Clinical Trial Registration Sr. Specialist will report to the Clinical Trial Registration Lead, providing operational support for the registration and maintenance of clinical trials into public registries in the US and EU.
Position Responsibilities:
Drive the processes for assigned protocol registration activities, ensuring timely, high-quality information is posted on clinical trial registries (Clinicaltrials.gov and EU PAS).
Liaise 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.
Provide maintenance support to the CT Registration Lead for assigned records to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov.
Submit registration updates to Clinicaltrials.gov on behalf of the clinical team, within global regulatory timelines.
Maintain study trackers, ensuring they are up to date weekly.
Educate stakeholders, as needed, on NIH detailed review criteria for registrations and the purpose and format of the different fields in the protocol registration form.
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 is highly desirable
Experience in clinical trial transparency or clinical trial execution work, or work related to quality and compliance in clinical research is 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
Strong written and oral communication skills
Strong organizational skills with the ability to multitask and prioritize
Travel Required: No
Exposure to Hazards/Disagreeable Conditions in the Work Environment: N/A
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.
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: R1582990
Updated: 2024-07-01 04:14:07.651 UTC
Location: Princeton-NJ
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.