Senior Clinical Operations Manager Princeton, NJ
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Job Location:
Princeton, NJ - USA
Monthly Salary:
$ 150770 - 182701
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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.
Position Summary
To lead and manage a cross functional Clinical Operations Unit ensuring delivery of clinical operations effectiveness in RCO-US.
Key Responsibilities
Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs) Clinical Trial
Monitors (CTMs) Clinical Trial Associates (CTAs) Site Relationship Managers Study Start-up Specialists and/or Site Contract Leads to ensure timely execution consistent with R&D and local research goals and priorities
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
Bachelors required preferably within life sciences or equivalent
Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs
For CT Monitor Line Managers Prior monitoring experience required
Significant experience in the planning conduct and management of clinical programs (Phase I-IV)
Demonstrated ability to drive project related activities
Previous supervisory and/or leadership experience (i.e. participation in task force initiative or cross functional team)
Previous resource allocation experience preferred
Experience mentoring and providing feedback to others
Competencies
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 (both in English and local language).
Software that must be used independently and without assistance (e.g. Microsoft Suite)
Microsoft Suite
Clinical Trial Management Systems
Working Conditions
Domestic travel to clinical trial sites
International travel where required
Overnight Absences Required (per typical month) 0-1
If you come across a role that intrigues you but doesnt 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.
Compensation Overview:
Princeton - NJ - US: $150770 - $182701
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.
Required Experience:
Manager
Key Skills
- Employee Evaluation
- Continuous Improvement
- FDA Regulations
- Management Experience
- Process Improvement
- Profit & Loss
- Operations Management
- Project Management
- Strategic Planning
- Leadership Experience
- P&L Management
- Supervising Experience
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
