Manager, Clinical Research Budgets/Contracts

Overview

Our team members are the heart of what makes us better.

At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Manager, Clinical Research Budgets/Contracts provides leadership during the clinical agreement and site level budget negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements and investigator budgets. This role necessitates providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management. This role requires a high level of interactive communication to set clear direction for the study teams and external Institutions.

Responsibilities

A day in the life of a Manager, Clinical Research Budgets/Contracts at Hackensack Meridian Health includes:

• Manages the coordination of site contract and budget activities.
• Develops and implements a robust, scalable and efficient country and site contracting and budgeting process and oversight across all trials.
• Provides guidance for HMH investigators on clinical trial development, including guidance on planning, implementation, milestone tracking/achievement for research billing.
• Provides policy and procedure interpretation to departments/divisions related to study financials and research billing compliance
• Develops queries and reports on the financial system, communicates with sponsors and ensures research billing compliance.
• Generates dashboard reporting to stakeholders in monthly/quarterly/annual tracking of all clinical trial revenue generation, receipt and appropriate allocation of funds to service providers and investigators.
• Works closely with the clinical study manager(s) responsible for assigned trials, the legal and finance groups.
• Develops and improves relationships with internal clients, internal stakeholders, CROs, and sponsors.
• Partners with colleagues in the Legal Department and other stakeholder groups, as needed, to continuously improve Hackensack Meridian Health's CTAs.
• Leads appropriate agenda topics of the team meeting and provide mentorship to line functions.
• Attends study team meetings to provide updates as to negotiation status and risks to deliverables and timelines.
• Reviews and monitors contract and grant proposal applications and awards, ensures compliance for clinical research as well as bench research, reviews and approves expenditures, delegates work flow, manages proposal activity with support staff and multiple Principal Investigators (PIs), monitors financial management of funding, interacts with other centralized offices..
• Leads the development of SOPs and will develop educational training programs as assigned.
• Reviews, negotiates, and monitors contracts for all vendors providing research related services, clinical trials, chart review, investigator initiated trials, other research projects and confidentiality agreements.
• Assigns clinical trial agreements to appropriate staff.
• Ensures all contract and budget requirements are addressed.
• Manages review of budgets for all studies.
• Works closely with regulatory staff, and clinical team reviewing the informed consent, protocols, and contract requirements.
• Escalates issues proactively to Director Clinical Research Business, and/or Clinical Operations teams to prevent delays in site activation timelines.
• Works on increasingly complex problems of diverse scopes requiring critical analysis and comprehensive evaluation of critical factors.
• Exercises independent judgment in developing methods and techniques to obtain solutions (and process improvements).
• Oversees the patient and revenue tracking through use of the Clinical Trial Management System (CTMS).
• Oversees the development of Medicare Coverage Analysis and research billing sheet for each clinical trial.
• Submits monthly, quarterly, and annual financial reports and other financial reports as requested.
• Manages outstanding receivable reports and oversees research collections activities.
• Oversees tracking and reporting of cash receipts, posting of payments and submitting of invoices and check requests.
• Coordinates and participates in internal and external meetings as needed.
• Maintains a professional approach respecting the dignity and confidentiality of associates, managers, and vendors.
• Interfaces internally with appropriate staff in each department HMH & Research Institute including finance, billing, data management, regulatory, investigator, clinical staff, and quality assurance.
• Manages multiple concurrent projects, paying special attention to competing deadlines, complexity, and priority.
• Provides key KPIs for Contracts, Budgets, and clinical trial finance to key stakeholders.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• Bachelor's diploma/degree in relevant area of study or 4 or more years of experience in a related area.
• Minimum 1-3 years of managerial experience and proven success in managing and leading a dynamic team of experienced and new analysts.
• Knowledge of clinical research and interpreting and comprehending complex clinical research protocols, budget exhibits and informed consent forms.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Knowledge of academic and government research administration policies and guidelines.
• Ability to analyze complex situations, identify solutions and make appropriate determinations.
• Ability to maintain professional demeanor and relationships with team members from all levels of an organization.
• Strong organizational skills with ability to coordinate activities across various units.
• Familiarity with National Coverage Determinations (NCD) including NCD 310.1, Local Coverage Determinations, and National Comprehensive Cancer Network (NCCN) Guidelines.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Education, Knowledge, Skills and Abilities Preferred:

• MBA/MHA/JD degree.
• Knowledge of GCPs governing clinical research.
• Experience with the following computer applications: OnCore, other clinical trial management system, electronic data capture system.
• Project Management

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

Our Network

Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility

As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.