Clinical Trial Study Manager I

Job Description

Clinical Trial Study Manager I - Baltimore, MD (Hybrid) - Monday-Friday 8:00AM-5:00PM

The Clinical Trials Study Manager 1 is primarily responsible for coordinating the execution of Oncology clinical trial projects involving the Haystack MRD liquid biopsy test, including managing the scope, timeline, and budget of assigned projects.  This position may also have direct line management responsibility of junior-level study management team members.  They will have indirect management responsibility of team members supporting clinical trial projects.

Pay Range: $78,700 - $141,700 / year

Salary offers are based on a wide range of factors, including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:
We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

• Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours 
• Best-in-class well-being programs
• Annual, no-cost health assessment program Blueprint for Wellness®
• healthyMINDS mental health program
• Vacation and Health/Flex Time
• 6 Holidays plus 1 "MyDay" off
• FinFit financial coaching and services
• 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
• Employee stock purchase plan
• Life and disability insurance, plus buy-up option
• Flexible Spending Accounts
• Annual incentive plans
• Matching gifts program
• Education assistance through MyQuest for Education
• Career advancement opportunities
• and so much more!

Responsibilities:

• Review the contracted scope, budget, and timeline to develop a plan of action or multiple plans of action to successfully complete the project.
• Coordinate with scientific and technical directors as the scientific leaders for the project.
• Coordinate with appropriate technical staff within the laboratory operations to ensure the operational plan is achievable and appropriate resources are available for the scope.
• Coordinate with the Director of Medical Affairs throughout the life of the project to ensure the scope, timeline, and budget are well understood, and also understand the escalation path for communicating issues.
• Manage and own client relationship throughout the study
• Identify, track, and manage risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.
• Identify new or out-of-scope requests from customers and communicate with Business Development so contract modifications can be implemented.
• Maintain official project records from inception to completion, including archiving.
• Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).
• Develop an overall project plan and maintain regular touch points to ensure that timelines are being met.
• Communicate with customers on regular operational items (project updates, scope alignment).
• Other duties as assigned.

Qualifications:

Required Work Experience:  

• 3-4  years of biotechnology experience or equivalent education and experience. 
• 1-2 years of previous clinical laboratory experience required. 
• 4-year degree required. Master's degree preferred.

Preferred Work Experience:  

• Previous experience in a GXP environment preferred. 
• 1-2 years of previous project management experience preferred. 

Physical and Mental Requirements:  

• Ability to sit for extended periods of time. 
• Ability to stand for extended periods of time. 
• Must regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. 
• Ability to use fine motor skills to operate office equipment. 
• Ability to receive and comprehend instructions verbally and/or in writing. 
• Ability to use logical reasoning for simple and complex problem-solving. 

Knowledge:  

• N/A

Skills:  

• Excellent verbal and written communication skills. 
• Exceptional interpersonal skills and business acumen.
• Strong organizational skills; very detail-oriented and a self-motivated problem solver.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

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Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.