Clinical Research & Innovation Manager, Pre-award
\nAtlantic Health Clinical Research & Innovation Institute – Sponsored Projects Administration
\nPosition Summary
\nThe 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.
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Duties and Responsibilities
\nDevelopment 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.
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Supervisory Responsibilities
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Other Desired Skills, Abilities, and Knowledge
\nDetail-oriented with analytical skills.
\nAbility to manage multiple projects under tight deadlines.
\nCollaborative and solutions-focused approach
\nA leader among peers; A leader of people.
\nAdditional Job Requirements
\n Member of a research-related professional organization
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\nAt 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:
\nWe have more than 900 community-based healthcare providers affiliated through Atlantic Medical Group.
\nWe 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:
\nAtlantic 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:
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Team Member Benefits
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\nNote: 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.
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EEO STATEMENT
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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
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