Trial Manager, Phase Iv

1 month ago

Mulgrave, Australia Bristol-Myers Squibb Full time

**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.

The Clinical Trial Manager, Phase IV/Late Development is responsible for operational execution of Phase IV /Late Development Book of Work across various therapeutic areas and study types. They act as point of contact for external study sponsors and internal stakeholders & manage protocols and drug supply within a complex matrix environment for successful and timely operational execution of research from start to end. It is an integral role, interacting with multiple stakeholders and leads directly to great outcomes for patients.

**Responsibilities**
- Ensures data entered in Clinical Trial Managements Systems is current and complete
- Focused on project management concepts to support management of issues, risks, timelines, and budget
- Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams
- Ensure inspection readiness of assigned trials and programs within country. Provide support to Health Authority inspection and pre-inspection activities

BMS-Sponsored Studies:

- Monitor trial progress and study budget
- Lead study team meetings
- Address and manage obstacles
- Identify issues and risks, escalating appropriately
- Oversee vendorsManage and comply with various quality and compliance systems

Non-BMS Sponsored projects:

- Lead operational start-up, maintenance, and close-out
- Serve as primary point of contact for study SponsorLiaise with Medical and global stakeholders to monitor study progress and ensure data deliverables are met

Pre-Approval Access (PAA)/Compassionate Access Programs:

- Lead company access programs for ANZ and Southeast Asia.
- Serve as primary point of contact for PAA
- Liaise with internal and external stakeholders to support unsolicited requestsMentor support to Trial PAA Specialist

Other:

- Participates in initiatives, working groups, serves as an SME, as assigned.

**Experience, skills and competencies**
- Bachelor's degree within Life Sciences or equivalent
- Experience in leading clinical trials demonstrating project management and organizational skills. Leading local and multi-functional teams
- Experience with electronic quality and compliance systems, as well as CTMS and electronic trial master file
- Thorough understanding of GCP, ICH Guidelines, and Country regulatory environment
- In-depth knowledge and understanding of clinical research processes, regulations, and methodology
- Demonstrated planning skills and independent decision-making ability
- Strong organization and time management skills; ability to effectively manage multiple competing priorities and work collaboratively cross
- functionally
- Demonstrated critical thinking and ability to proactively identify and mitigate risks.
- Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
- Skilled in the use of technology
- Excellent verbal and written communication skills

LinkedIn-Hybrid

**Uniquely Interesting Work, Life-changing Careers**

**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 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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