Manager, Grants & Research - Pre-Award Clinical Trials

Atlantic Health System • Full-time • Morristown, New Jersey, United States • 2h ago

Clinical Research & Innovation Manager, Pre-award

Atlantic Health Clinical Research & Innovation Institute – Sponsored Projects Administration

Position Summary

The Manager, Pre-Award Clinical Trials, oversees all pre-award activities related to sponsored clinical research studies. This role leads a team responsible for clinical trial budget development, Medicare Coverage Analysis (MCA), clinical trial agreement (CTA) coordination, study startup financial preparations, sponsor negotiations, and compliance with institutional policies and sponsor requirements. The Manager serves as the primary operational leader for financial and contractual startup activities. They collaborate closely with investigators, research staff, Sponsored Projects Administration, Legal, Revenue Cycle, Compliance, Research Finance, and industry sponsors to ensure efficient study activation while protecting institutional financial and regulatory interests. Ensures a smooth transition to post-award activity, keeping open communication with colleagues on that side.

Duties and Responsibilities

Development of clinical trial budgets for industry-sponsored and investigator-initiated studies with funding.
Ensure budgets accurately capture all protocol-required activities, personnel effort, pass-through costs, pharmacy services, specimen processing, imaging, laboratory services, and institutional overhead expenses.
Review protocol schedules of events to identify billable and sponsor-funded activities.
Establish and maintain fair market value (FMV) standards for study procedures and research services.
Lead budget negotiations with pharmaceutical, biotechnology, CRO, and device sponsors.
Ensure costs are covered.
Conduct and/or oversee completion of Medicare Coverage Analyses (MCAs) for clinical research studies.
Ensure determination of routine costs and research-only procedures, sponsor-paid services, and qualifying clinical trial criteria is documented.
Maintain compliance with NCD 310.1 and institutional billing requirements.
Collaborate with clinical team members, compliance, and revenue cycle to mitigate billing risk.
Ensure all documentation is organized in a complete and accurate fashion.
Oversee review and negotiation of CTAs, CDAs, DUAs, RSAs, MTAs, and CUAs.
Partner with legal, sponsors, and sponsored projects administration to facilitate all levels of approval before issuing Final Authorization to Proceed letters.
Monitor turnaround times and identify issues impacting pre-award operations.

Supervisory Responsibilities

Leads, motivates, and supervises a team of pre-award clinical trial professionals through operational workflows and study startup
Establishes expectations and performance metrics for pre-award activity and routinely evaluates and reports.
Monitors timelines, identifies bottlenecks, and implements improvement plans as needed.
Engagement-driven.
Recruits, trains, mentors, and evaluates team performance. Conducts workload assessment and resource planning.
Promotes a culture of service, accountability, and continuous improvement.

Qualifications

Bachelor’s degree in life sciences, healthcare administration, or a related field (master’s preferred).
Up to 5+ years of experience in clinical research administration, with a focus on pre-award and study start-up activities.
Proven ability to draft/redline, develop, and negotiate clinical trial agreements and budgets.
Excellent organizational, communication, and stakeholder management skills.
Demonstrated ability to negotiate effectively with industry sponsors and CROs.
Strong understanding of CTMS and other research administration systems.

Other Desired Skills, Abilities, and Knowledge

Detail-oriented with analytical skills.

Ability to manage multiple projects under tight deadlines.

Collaborative and solutions-focused approach

A leader among peers; A leader of people.

Additional Job Requirements

Member of a research-related professional organization

At Atlantic Health, our promise to our communities is; Anyone who enters one of our facilities will receive the highest quality care delivered at the right time, at the right place, and at the right cost. This commitment is also echoed in the respect, development and opportunities we give to our more than 22,000 team members. Headquarters in Morristown, New Jersey, we are one of the leading non-profit health care systems in the nation. Our facilities and sites of care include:

Atlantic Health Morristown Medical Center, Morristown, NJ
Atlantic Health Overlook Medical Center, Summit, NJ
Atlantic Health Newton Medical Center, Newton, NJ
Atlantic Health Chilton Medical Center, Pompton Plains, NJ
Atlantic Health Hackettstown Medical Center, Hackettstown, NJ
Atlantic Health Goryeb Children's Hospital, Morristown, NJ
Atlantic Health CentraState Healthcare System, Freehold, NJ
Atlantic Medical Group
Atlantic Visiting Nurse
Atlantic Mobile Health
Atlantic Rehabilitation

We have more than 900 community-based healthcare providers affiliated through Atlantic Medical Group.

We have received awards and recognition for the services we have provided to our patients, team members and communities. Below are just a few of our accolades:

Chosen for 17 years by Fortune as one of the magazine’s “100 Best Companies to Work For."
Atlantic Health Morristown and Atlantic Health Overlook Named by Newsweek as two of the “World’s Best Hospitals” in 2026.
Atlantic Health Morristown and Atlantic Health Overlook ranked within the top three hospitals in New Jersey by U.S. News & World Report’s 2025-2026 Best Hospital rankings.
Atlantic Health scored four “A” grades by The Leapfrog Group in its Fall 2025 Hospital Safety Grades, performance measures reflecting errors, accidents, injuries and injections, as well as systems hospitals have in place to prevent harm.
Atlantic Health Morristown and Atlantic Health Overlook are New Jersey's only hospitals to be named among America's 50 Best hospitals by Healthgrades in 2026.
Named by Becker's Healthcare as one of the "165 Top Places to Work in Healthcare – 2026.
Atlantic Health Morristown, Atlantic Health Overlook, Atlantic Health Chilton and Atlantic Health Newton all Forbes Top Hospitals for 2026.
Named by Newsweek as one of America’s Greatest Workplaces for Inclusion & Diversity 2025.
Atlantic Health rated LEVEL 9 - 2025 CHIME Digital Health Most Wired.

Atlantic Health offers a competitive and comprehensive Total Rewards package that supports the health, financial security, and well-being of all team members. Offerings vary based on role level (Team Member, Director, Executive). Below is a general summary, with role-specific enhancements highlighted:

Team Member Benefits

Medical, Dental, Vision, Prescription Coverage (22.5 hours per week or above for full-time and part-time team members)
Life & AD&D Insurance.
Short-Term and Long-Term Disability (with options to supplement)
403(b) Retirement Plan: Employer match, additional non-elective contribution
PTO & Paid Sick Leave
Tuition Assistance, Advancement & Academic Advising
Parental, Adoption, Surrogacy Leave
Backup and On-Site Childcare
Well-Being Rewards
Employee Assistance Program (EAP)
Fertility Benefits, Healthy Pregnancy Program
Flexible Spending & Commuter Accounts
Pet, Home & Auto, Identity Theft and Legal Insurance

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Note: In Compliance with the NJ Pay Transparency Act (effective Sunday, June 1, 2025), all job postings will include the hourly wage or salary (or a range), as well as this summary of benefits. Final compensation and benefit eligibility may vary by role and employment status and will be confirmed at the time of offer.

EEO STATEMENT

Atlantic Health, Inc. is an equal employment opportunity employer and federal contractor or subcontractor and therefore abides by applicable laws to protect applicants and employees from discrimination in hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral, and other aspects of employment, on the basis of race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, citizenship status, disability, age, genetics, or veteran

Atlantic Health System is at the forefront of medicine, setting standards for quality health care powered by a workforce of more than 18,000 team members and 4,800 affiliated physicians dedicated to building healthier communities, the system offers more than 400 sites of care, including eight award-winning medical centers. Specializing in cardiovascular care, cancer care, orthopedics, neuroscience, pediatrics, women's health and rehabilitation medicine. Atlantic Medical Group, comprised of 1,000 physicians and advanced practice providers, represents one of the largest multi-specialty practices in New Jersey and includes finance, legal, marketing, human resources, talent acquisition, ISS and more. Caring for our patients, our team members and the communities we serve is our central mission.