IMCS Group · 1 month ago
Non-Clinical - Administrative/Administration Manager
Anaheim, CA
Full-time
Onsite
Senior Level
7+ years expIMCS Group is seeking a Clinical Research Manager who will oversee the strategic vision and operations of the clinical research finance department. The role involves managing daily operations, ensuring compliance with regulations, and facilitating communication among various stakeholders.
Staffing & Recruiting
Responsibilities
Under the supervision of the Director, the Manager of Clinical Research is responsible for assuring the strategic vision, directions and operations of the clinical research finance department are implemented and adhered to by all staff
Responsible for oversight of the day to day operations of the clinical research finance team
Responsibilities include compliance with regulations and assure good communication between the various ministries, stakeholders and leadership
Assists in developing, implementing and maintaining policies and procedures
Assists in providing on-going formal and informal training for research staff
Manage Human Resource functions of the Department including recruitment, hiring, career development, performance evaluations, disciplinary actions and day to day Human Resource functions
Responsible for overseeing the development of research contracting and budgeting standards
Directs the negotiation of contracts for clinical trials and determination of internal costs and development of internal budget for negotiations of sponsored and investigator initiated clinical trials in compliance with applicable state and federal laws and regulations, especially Medicare and Stark Law
Lead the development and implementation of study builds in the clinical trial management system (CTMS)
Oversee HR functions for the finance team, including recruitment, hiring, performance evaluations, disciplinary actions, career development, and daily operations
Collaborate with leadership to develop and implement strategic plans, allocate resources to support growth, and foster professional development and shared decision-making among staff
Facilitate transparent communication and collaboration with clinical research programs, Clinical Program Services, and other key stakeholders regarding operations, contracts, budgets, finance, and CTMS
Build and maintain collaborative relationships across departments, hospital leadership, physician investigators, and external research partners
Lead team responsible for internal budget development and negotiations, ensuring compliance with FMV, Medicare guidelines, and state laws
Manage department budgets, financial tracking, and month-end accounting processes
Direct contract negotiation strategies with clinical trial sponsors
Provide expertise in developing standard clinical trial agreements and collaborate with Legal Affairs to align contracts with site needs
Manage and lead the month end accounting process, reviewing for quality assurance, and accuracy and addressing areas of concern
Supervise post-award financial management, including invoicing, revenue accrual, vendor payments, and financial reporting
Ensure accurate billing, coding, and compliance with Medicare research funding rules
Lead the development and implementation of CTMS, aligning system functionality with clinical protocols, contract terms, and financial workflows
Balance technology investment with compliance and ROI
Provides resources and experiences to team to interpret clinical trial protocols, contracts and budgets into study specific builds, as well as allowing for patient management, and the AR and AP activities of all clinical trials
Ensure adherence to federal regulations and system policies in clinical trials
Develop and maintain QA processes, data controls, and compliance standards to protect organizational interests
Knowledgable of Medicare research funding rules and regulations and ensures appropriate billing and coding of patient services to correct research account
Aid in developing standard operating procedures and policies to improve departmental efficiency and performance
Identify and lead quality improvement initiatives
Institutes controls to assure accuracy, completeness and confidentiality of research data
Identifies, facilitates and coordinates quality improvement opportunities; develops local QA process to address areas of need
Demonstrate deep understanding of the clinical trial lifecycle, including feasibility, budgeting, contract alignment, reporting, and operational implementation
Advanced understanding and working knowledge of accounting platforms, research grant management, and clinical trial platforms
Develop and implement strategies to increase revenue and accelerate project timelines, ensuring competitiveness and goal achievement
Qualification
Required
ACRP or SOCRA certification, or other Clinical Research Certification
Bachelor's Degree Required
7 years of Clinical research experience REQUIRED
5 years in management or supervision of clinical trials REQUIRED
5 years Experience in clinical research finance REQUIRED
Experience in managing data collection, reporting, outcomes, quality improvement, standards/pathways REQUIRED
Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations surrounding human research REQUIRED
Experience with working with Pharmaceutical and FDA agency representatives REQUIRED
Computer literate to include advanced level proficiency in Microsoft Office Programs (Word, Excel, Access and PowerPoint), E-mail and Internet
Thorough knowledge and understanding of HIPPA, GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
Extensive Knowledge of DHHS, FDA, NCI, NIH, OHRP and other relevant regulations concerning research and compliance
Knowledgeable of principles of accounting and contract law affecting clinical trials
Ability to successfully budget and negotiate industry contracts for sponsored clinical trials
Highly organized and attentive to details, problem solving abilities and ability to work with minimal supervision
Highly motivated and able to take initiative
Ability to prioritize, organize, plan, and implement as well as handle multiple projects/problems simultaneously within a fast paced environment; able to collect and manage large amount of data and maintain databases; communicates progress, challenges and results effectively
Knowledge of operations, including human resource, budget management and work flow planning
Ability to plan, chair, document and follow-up on administrative and related meetings
Ability to work independently and with minimal supervision
Ability to be flexible, multi task and switch priorities as well as work comfortably in a deadline driven environment
Communicates well with physicians, patients, sponsors and staff on interpersonal and technical levels, both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information
Interacts favorably with people by phone and in person, and work effectively as part of a team
Demonstrate communication, leadership, and team building skills; evidence of this should includes dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others
Excellent written/verbal communication skills to effectively interact with all levels of management, departments, and users
Preferred
Master's Degree Preferred
Company
IMCS Group
IMCS Group is an IT, Healthcare, and Professional Staffing Company that helps Enterprises optimize the business value of their Staffing investments and enables them to achieve world-class business performance.
201-500 employees
H1B Sponsorship
IMCS Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (16)
2023 (33)
2022 (32)
2021 (47)
2020 (82)
Funding
Current Stage
Growth StageLeadership Team
Satish G Kumar
Founder and CEO
Kathleen Thompson
Diretor Client Partnership
Company data provided by crunchbase