Clinical Research Manager

Fresenius Medical Care•Las Vegas, NV

1d•Onsite

About The Position

This position provides support to Frenova Renal Research and the contract research organization (CRO) by monitoring and tracking the progress of clinical study activity at research sites. It also provides support with regulatory agency and sponsor inspections/audits as needed. Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease, with approximately 4.5 million patients worldwide regularly undergoing dialysis treatment. The company cares for around 292,000 dialysis patients globally and operates around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. The aim is to continuously improve patients’ quality of life by offering high-quality products, innovative technologies, and treatment concepts.

Requirements

Bachelor’s degree in Nursing or Health Sciences, or equivalent experience
Clinical research certification required
Minimum of 5 years of clinic research experience
Minimum of 3 years supervisory experience, project/program management experience or direct management
Experience in conducting, managing, monitoring, and/or analyzing clinical research projects
Demonstrated knowledge of Good Clinical Practice and ICH, as well as OSHA standards and other site specific regulations
Excellent communication skills (interpersonal, verbal, written), attention to detail, organizational and prioritizing skills, and time management skills
Strong computer skills

Nice To Haves

Advanced degree desirable
Project/program management experience or direct management preferred, preferably at the site or CRO level
Experience using a Clinical Trials Management System preferred

Responsibilities

Manage clinical research staff including but not limited to: interviewing potential new staff, training of new and existing staff, staff coverage, and team meetings
Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations
Ensure the clinical research project team(s) for a specific trial understands the project objectives, timelines, and tasks
Ensure research project enrollment goals are met according to project timelines
Develop or review study specific site budgets, providing constructive feedback as needed
Review confidentiality disclosure agreements and clinical trial agreements
Monitor and contain site expenses
Review study budget and line item payments against predicted accrual
Ensure clinical research, physician office and facility staff are prepared for on-site visits by CRO or sponsor
Maintain a state of audit-readiness
Manage a site level quality review program
Serve as a resource for clinical research staff by maintaining up to date knowledge of medical terminology and Good Clinical Practice
Provide resource planning for office and facility-related research
Support clinical research staff as needed to ensure research subject safety and quality of data
Oversee use of Clinical Trials Management System
Ensure research-related regulatory approvals are obtained
Liaise with sponsors, CROs, practice members and Frenova Renal Research staff
Attend investigators meetings as necessary
Maintain a positive and productive working relationship with physicians and staff
Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters
Receive assignments in the form of objectives and determine how to use resources to meet schedules and goals
Follow processes and operational policies in selecting methods and techniques for obtaining solutions
Interpret and recommend changes to operational policies as needed, and establish procedures that positively affect Frenova Renal Research’s provided services
Participate and present at meetings with internal and external representatives as needed, often leading a cooperative effort among members of a project team
Interact with internal departments and external customers, particularly in problem resolution
Act as an advisor to subordinate(s) to meet schedules and/or resolve technical problems
Provide technical guidance as needed
Assist with various projects as assigned
Other duties as assigned
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.