Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Overall responsibility
The Project Management Manager (PM Mgr) will be responsible for operational planning, scheduling, and managing of deliverables associated with sponsor protocols. The PM Mgr will work with sponsor requirements utilizing the project-specific Statement of Work, protocols and other data to identify requirements for planning, budgeting, estimating enrollment requirements and forecasting. The PM Mgr will be responsible for the operational management and oversight of clinical investigator sites of SUMMIT. The PM Mgr will monitor site performance, developing a standard method for the multi-site management system and ensure the management system is deployed to Summit site partners. The PM Mgr will ensure successful completion of all clinical activities under the responsibility of SUMMIT investigator sites within the required timelines. The PM Mgr will be the primary contact for the client (Sponsor and CRO by delegation), the SUMMIT Investigator Sites, and will be responsible for key study performance information, including start up metrics, enrollment, data collection timelines and quality. The PM Mgr will be responsible for directly managing performance and metrics of PM staff.
The PM Mgr will work in close collaboration with the Executive Management team of SUMMIT.
Key tasks:
Requirements:
The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Supervisory Responsibilities:
The PM Manager will be responsible for the management and oversight of the Project Management Team.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Language Ability:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Math Ability:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills:
To perform this job successfully, an individual should have knowledge of Microsoft Office, Microsoft Excel, Explorer, Google Chrome, Mozilla Firefox, web based enterprise solutions, and project management software.
Specialized Training:
Certificates and Licenses:
Valid driver’s license and personal auto insurance
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use hands, reach with hands and arms, and talk or hear. The employee is occasionally required to stoop, kneel, crouch or crawl, and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color.
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