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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 .

· Identifies, evaluates, and recommends new potential investigators/sites on an on-going basis through medical community networking or internal BMS requests, to assist in the placement of planned clinical studies with qualified investigators.

· Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts Site Initiation visits in collaboration with RCO Site Managers and/or CCO Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.

· Reviews site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable BMS SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes, but is not limited to:

Ø Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.

Ø Ensures quality of data submitted from study sites and assures timely submission of data.

Ø Ensures safety and protection of study subjects according to the monitoring plan, BMS SOPs, and ICH and/or FDA GCP Guidelines.

Ø Manages overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives.

Ø Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed. Ensures documented

Ø Follow-up to all outstanding issues, within the scope of this position profile. Appropriately escalates serious or outstanding issues to line manager and project team members.

Ø Facilitates the Regulatory Compliance audit process, as needed.

Ø Provides monitoring assistance to site monitor colleagues, as requested.

· Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, tactful and objective manner.

· Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, and pharmacist), peers, and BMS office-based personnel. Uses multiple technologies to maintain open and frequent communication with BMS personnel.

· Resolves most study-related issues independently, with management support. Uses functional expertise and exercises good judgment in seeking appropriate counsel and authorization.

· Exhibits high degree of flexibility when facing changes such as program priorities, protocol modifications, enrollment challenges, etc.

· Employs good fiscal management to conserve the costs of departmental operation and controls travel expenses.

· Participates in and or presents in divisional or departmental meetings.

· Participates in appropriate professional organizations, meetings, symposia, and continuing education programs to maintain knowledge and expertise across multi-therapeutic areas.

· Participates in departmental/divisional special projects, cross-functional work groups, task forces and study feasibilities.

· Performs other tasks, as assigned or requested by line manager.

Clinical Site Monitor 2

· Demonstrates excellent understanding of expected areas of competence

· Independently makes decisions and takes action

· Strong knowledge of the integrated clinical development process

· Works independently

· Leads work streams, process improvement initiative and provides insightful feedback and suggestions within the team

· Positive role model

· Proactively identifies and resolves site issues

· Shares best practices openly and works as a role model within the team

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: R1585905

Updated: 2024-10-19 01:40:39.509 UTC

Location: Shanghai-CN

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.