Job Information
Bristol Myers Squibb (Sr.)Clinical Trial Manager in United States
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 .
Position Summary / Objective
The clinical site manager position is to drive and monitoring the overall progress of a clinical trial conducting in China, includes but not limited to patient recruitment, data collection, GCP compliance and budget control. Clinical site manager should have close collaboration with PTM, CDR, MM and quality assurance colleagues.
Position Responsibilities
Independently monitors the progress of assigned investigator sites by maintaining close contact with site personnel and internal project team. Coordinates and maintains effective communication (oral, written) and serves as a BMS contact for the investigator. Provides feedback and status updates to internal stakeholders on an ongoing basis.
Demonstrates an understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project. Works closely with other study team members in the coordination of study activities to meet the appropriate timelines at the site/protocol level.
Independently manages activities at the site and monitors study progress by providing guidance as required and by close collaboration with other key stakeholders (e.g. Medical Monitor, Protocol Manager, Clinical Trial Associates, Contract Administrators, Clinical Data Quality Managers and Site Monitor(s)) as applicable.
Documents substantive contacts concisely and in accordance with SOPs.
Identifies potential issues at the site or protocol level and suggests resolutions. Answers and resolves routine or site related questions independently. Knows when to defer difficult or unresolved issues to the appropriate team member.
Independently disseminates information to appropriate BMS team members to ensure timelines are met (e.g. Site Manager(s), Clinical Data Quality Manager(s), Site Monitors, Clinical Trial Associate, ContractAdministrators). Proactively identifies and resolves issues noted during site management which impact the overall protocol timelines and informs the appropriate BMS team members (e.g. Protocol Manager, Site Monitors, Line Manage) and coordinates follow-up.
Ensures program level standards are applied at the protocol level from study start-up to data base lock. Shares experiences and best practices through coaching and feedback.
Degree Requirements
Knowledge equivalent to that attained with a Bachelor’s degree in Life Sciences, Allied Health, Pharmacy, Nursing and clinically related or relevant experience.
•Thorough understanding of ICH-GCP guidelines and local regulatory guidelines or regulations as they apply to protocol/site management.
•Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met.
•Knowledge of the pharmaceutical industry and of the pre-clinical, clinical, regulatory and commercial components.
• A detailed understanding of project planning and management methods.
• Knowledge of Database Management Systems.
Experience Requirements
• Experience with aspects of project management.
Experience in the conduct and management of Investigator sites from start-up to database lock within expectations set by management.
• Experience in effective implementation of clinical plans/documents and document preparation.
• Previous experience working in a team environment within a matrix organization.
Key Competency Requirements
• Focus on the needs and perspectives of colleagues and customers.
• Make and act on decisions while balancing speed, quality and risk.
• Use input from key stakeholders and engage in constructive dialogue to make
• Focus on the needs and perspectives of colleagues and customers.
• Seek diverse viewpoints.
• Communicate directly, openly and honestly.
• Learn, apply and share lessons from experience.
• Embrace and adapt to change.
• Challenge the status quo to simplify work and improve results.
• Share knowledge and learning with others.
• Seek and give feedback and coaching.
• Meet challenges with enthusiasm.
Travel Required
Nature and frequency, if required
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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
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: R1564461
Updated: 2024-04-26 01:25:11.837 UTC
Location: -Shanghai
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.