Clinical Operations Project Manager

Reynolds American is evolving at pace - truly like no other organization.  

To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey! 

WE ARE LOOKING FOR A Clinical Operations Project Manager

                SENIORITY LEVEL: Junior Level 

FUNCTION: SR&D

LOCATION: Winston-Salem, NC

ROLE POSITIONING AND OBJECTIVES 

This role is part of Clinical Studies

The role is responsible for providing sponsor oversight to the conduct of clinical trials intended for FDA submission

Reports to: Director, Clinical Operations

Reporting Level: 0

Geographic Scope: Local 

WHAT YOU WILL BE ACCOUNTABLE FOR 

• Direct, supervise, and/or coordinate a program of studies or the day-to-day execution of clinical studies outsourced to contract research organizations.
• Lead and/or work collaboratively with project study teams comprised of internal staff and external vendors.
• Develop and maintain relationships for oversight of contracted vendors
• Review, interpret, and/or apply research concepts from regulatory agencies to RAIS clinical studies.
• Ensure that studies are designed and conducted in compliance with Good Clinical Practices (GCP) requirements, applicable FDA regulations/guidance, and RAIS Standard Operating Procedures.
• Contribute to or assist with the study design and interpretation of resulting data to support product development, regulatory submissions, and exploratory research.
• Provide thought leadership on clinical operations process improvements

CAN THIS BE YOUR FUTURE ROLE?  

• Are you aware that this position is NOT remote?
• Are you familiar with FDA requirements for tobacco product submissions?

ESSENTIAL EXPERIENCE, SKILLS AND KNOWLEDGE 

• Three to five years of work experience in clinical research, preferably with experience in leading clinical studies.
• Ability to drive collaborative efforts cross-functionally and externally with outsourced vendors.
• Excellent relationship management
• Strong project management skills
• Critical Thinking skills
• Ability to work and make decisions with minimal supervision.
• PhD, Master’s, or Bachelor’s degree required in biology, chemistry, toxicology, pharmacy, public health, clinical research, or related discipline; or equivalent experience.
• Demonstrated high level project management skills, especially timeline and team management

BENEFICIAL  

• Experience with FDA regulatory submissions.
• CCRC, CCRA, CCRP or Project Management  certification.

Job Number: 37575

Reynolds American Incorporated is positively transforming the tobacco industry. We’re a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are redefining the ways adult tobacco consumers enjoy tobacco in the 21st century.

When other companies talk about growth, they only talk about size. At Reynolds American, we focus on the growth of our people. We take pride in each other’s growth and well-being throughout our careers. We invest in your career and total well-being because we know our companies succeed when our people thrive.

ABOUT OUR ORGANIZATION:

Reynolds American Inc. is an indirect, wholly owned subsidiary of British American Tobacco p.l.c., and the U.S. parent company of R. J. Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; Modoral Brands, Inc.; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; Reynolds Brands, Inc.; and Vuse Stores LLC.  This position is with [[custContractualLE]] .

Here, you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.

Compensation/Targeted Bonus

• Competitive Annual Salary
• Targeted Annual Bonus
• Relocation assistance available for those who qualify.

Benefit Summary

Our company offers very competitive benefit plans, including:

• 401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation. Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
• Comprehensive health- and welfare-benefits package
• Eleven paid company holidays annually, plus a generous paid vacation plan based on length of service
• Company-paid sick and personal days, funeral leave and jury duty leave; Also Parental leave/Reduced Work Schedule
• Confidential personal financial counseling service
• On-site health clinics and fitness centers
• A matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
• Health-care advocacy service
• Volunteer service opportunities
• Federal credit union membership through Allegacy Federal Credit Union
• Extensive training opportunities  

Reynolds American Inc. and its affiliated companies is an Equal Opportunity / Affirmative Action Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Our organization offers a level of challenge, responsibility and creativity for motivated employees that stands apart from the crowd.

We are also committed to employing a diverse workforce and valuing different perspectives, experiences and talents to maximize the company's potential for successfully achieving its business objectives.

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Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly via email at TalentAcquisition@RJRT.com.

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