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The Clinical Operations Manager, Monitoring, is responsible for the execution of phase I-IV clinical studies & will lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in RCO across Australia & New Zealand.

Responsibilities

• Supervises and coordinates the work assignments and performance of Clinical Operations staff (Clinical Trial Monitors)

• Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.

• Anticipates resource needs and provides workload evaluations and task assignments.

• Allocates and assign study resources in alignment with R&D and local research goals and priorities.

• Supervises clinical trial execution at country level including supervising study metrics and team performance.

• Approves study fee funds and payments based on grant of authority

• May propose and/or validate country study targets.

• May support Health Authority inspection and pre-inspection activities.

• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

• Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available.

• Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met.

• Together with the RCO management tracks and manages performance metrics for Clinical Operations staff.

• Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit.

• Point of Contact for FSP staff within the country.

• Managing the hiring, performance management and succession planning of staff.

• Performing general and human resource administrative functions.

• Participation in performance calibration and talent review meetings.

• Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources).

• When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager.

• Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed.

• Manage partnerships with critical accounts / sites.

Qualifications, experience and competencies

Our ideal candidate will have a minimum of 5 years pharmaceutical industry experience in Clinical Research (monitoring) or Medical Affairs including significant experience in planning, conducting and managing clinical programs, with supervisory/leadership/mentoring experience and the ability to drive project related activities. In addition:

• Bachelor's Degree within Life Sciences or equivalent

• In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs

• In depth knowledge and understanding of clinical research processes, regulations and methodology

• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management

• Demonstrated organizational and planning skills and independent decision-making ability

• Strong organization and time management skills and ability to effectively manage multiple competing priorities

• Outstanding interpersonal, oral and written communication skills to influence, inform or guide others

• Good verbal and written communication skills

• Independent use of Microsoft Suite and Clinical Trial Management Systems

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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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