Diagnostic Laboratory Clinical Study Manager II

Overview

Diagnostic Laboratory Clinical Study Manager II - Baltimore, MD - Monday - Friday 8:00AM-5:00PM

 

The Diagnostic Laboratory Clinical Study Manager II is primarily responsible for the management of oncology clinical studies  involving Haystack MRD, a Next Generation Sequencing (NGS) based test by Quest Diagnostics.  This position is responsible for coordinating all study-related activities from study initiation through completion.  They will serve as the primary contact for clinical research personnel, and liaise with all internal teams to drive successful execution of clinical studies.

 

Pay Range: $88,700+ per 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/Dental/Vision for FT employees who work 30+ hours • 15 PTO days first year• Paid Holidays• Annual Bonus Opportunity • 401(k) with matching contributions• Variable compensation plan (AIP) bonus• Employee Stock Purchase Plan (ESPP)• Employee Assistance Program (EAP)• Blueprint for Wellness• Tuition Reimbursement for undergraduate and graduate programs for FT employees who work 30+ hours • Opportunities for career advancement • Training provided!

Responsibilities

• Review contracted scope, budget, and timeline to develop a plan of action for successful execution of the project.
• Develop study documentation, including study-specific manuals, analytical work plans, test requisition forms, sample transfer manifests, clinical data forms, and regulatory documentation as required.
• Coordinate with appropriate internal teams including scientific, regulatory, and laboratory staff to ensure operational plan is achievable and appropriate resources are available.
• Develop presentations to lead study kick-off calls as well as regular study update calls.
• Send meeting agendas and summaries before and after all meetings to ensure all expectations and action items are clear.
• Serve as the primary point of contact with clinical research personnel, responding to all inquiries promptly.
• Communicate regularly with internal teams throughout the life of the project to ensure expectations and timelines are well understood and adhered to.
• Hold all parties accountable to deliverables and timelines.
• Maintain study tracking documentation with up-to-date status of all study components, including patient enrollment, sample inventory, sample testing progress, data reported, and other study progress metrics.
• Set up new studies in the LIMS.
• Provide oversight of sample accessioning and serve as a liaison between clinical research and laboratory personnel to resolve all sample discrepancies promptly.
• Understand escalation path for communicating issues.
• Manage and own client relationship throughout the study.
• Identify, track and manage risks that may impact the ability to successfully complete the scope of the project in the timeline or budget available.
• Identify new or out of scope requests from customer and communicate with Business Development so contract modifications can be implemented.
• Maintain official project records from inception to completion.
• Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).
• Other duties as assigned.

Qualifications

Required Work Experience: 

• 5 to 8 years of diagnostic laboratory experience or equivalent education and experience.
• 2 years of clinical study managing experience.

Preferred Work Experience: 

• Previous experience in a GXP environment preferred.
• 3+ years of previous diagnostic laboratory experience.
• Oncology experience. 

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 an