Clinical Trial Support 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 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 Summary-

Reconcile and Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs

Resposibikities-

• In conjunction with the Submission Manager, and use of technologies, simplify the end-to-end process for Clinical Trial documents, maintenance and submissions
• Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs.
• Partners with the Submission Manager for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents.
• Ensures documents are formatted appropriately and Submission Ready Compliant (SRC)
• In collaboration with out outsourced partners, creates site numbers for new and ongoing clinical trials.
• Enters site milestones and regulatory approvals dates to maintain the quality health of the trail assigned to.
• Ensures Drug shipment address are entered correctly, and feed to SAP to enable IP Supply to sites.
• Performs a reconciliation of Veeva (eTMF/CTMS) to ensure accurate data is available and reflecting correctly.
• Proactively analyzes and drives efficient problem solving within team's control.
• Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items.
• Demonstrates thorough knowledge of relevant BMS SOPs and policies and the ability to provide timely guidance in their application to Protocol and/or Program teams. Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable.
• Demonstrates strong project management skills
• Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).
• Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
• Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents.
• Other duties as assigned to support Clinical Trials.
• Performs other tasks as assigned.
  
  

Experience Required-

• 2-4 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field.
• Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma.
• Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred
• Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies.
  
  

Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.

Key Compitencies-

• Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
• Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
• Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
• Ability to sustain high levels of performance in a constantly changing environment.
• Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
• Ability to prioritize work and assess risk to meet the needs of the organization.
• Demonstrated ability to work independently and seek out support when needed.
• Proactive, adaptable and able to modify personal and organizational work style to meet the needs of the business.
• Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
• Strong understanding of GCPs, ICH and regulatory regulations and guidelines as they apply to protocol management and program strategy.
• Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
• Strong understanding of protocol-related documents, and document management systems (e.g. CORE template).
• Ability to manage complex issues and proactively apply critical thinking to address challenges. Some positions may require experience in a specific therapeutic area.
• Exceptional written and oral communication skills."
  
  

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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 [email protected] . 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.

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