Clinical Research Manager

New Haven
Oct 05, 2017
Nov 02, 2017
Employer Type
Direct Employer
Employment Type
Full Time
The Clinical Research Manager will report to the Assistant Director for Clinical Research and be responsible for the oversight of staff to ensure operational processes are in place for the compliance with study protocols, and regulatory requirements. The Clinical Research Manager will collaborate with Study Investigators to assess and implement complex trials for the research team, manage oversight of protocol conduct and ensures that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines.
Our client is one of the most well-known research facilities in the country. With having been around for over a century, our client is an establishment. By working for our client, you will be a part of a booming industry that is constantly making strides towards the future in its field.
Monitor federal and state regulations for new guidance, updates, or policies.
Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department of the University.
Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions, and assistance as needed.
Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments.
Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments.
Manages the use of facilities in one or more departments including office space, workstations, equipment, and office supplies.
Manages administrative support for activities of one or more departments to ensure timely completion of projects.
Manages and coordinates training sessions for assigned departments when new policies or practices are adopted.
Ensures compliance with University and federal regulations as they apply to the assigned departments.
Identifies, plans, and develops administrative policies for the assigned departments.
Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department.
Assesses and makes recommendations regarding staff development and staffing levels.
Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis.
Manages a staff of exempt and non-exempt employees.
May perform other duties as assigned.

Bachelor's Degree in related field and three years of related experience or an equivalent combination of education and experience.

Proven ability to manage a team of research professionals.
Ability to manage and monitor the policies, practices, and procedures of licensed and unlicensed staff.
Proven ability to develop specific short- and long-term objectives for staff.
Demonstrated ability to ensure appropriate infrastructure by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies, and regulation while ensuring participant safety.
Strong knowledge of Good Clinical Practice guidelines.
Proven ability interpreting federal, state, University and sponsor policies and regulations.
Demonstrated ability with interpreting complex oncology clinical trial protocols and federal, state, local guidelines.
Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines.
Extreme flexibility in work focus; ability to switch among several different projects without any adverse effects.
Demonstrated ability to report on the status of project deliverables and draft and submit project updates to team and study sponsor.
Certified Clinical Research Professional (CCRP).

Company Description:

At HumanEdge, we create great hiring experiences for candidates and clients alike. We do it by applying our skills, energy, integrity and understanding of both individual needs and market forces to make the right match for all types of positions, including traditional contract assignments, career-changing direct searches, and freelance gigs. We know that you're more than a skill set and cluster of job experiences -- you're a whole person with big dreams and ambitions. When you work with us, you partner with a firm committed to helping drive your success with ongoing support, guidance, and tangible opportunities. For over 30 years we've helped candidates like you make the right move in a wide array of industries and variety of positions

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