Manager – Clinical Research Pre-Award - Pre-Award Clinical Trials

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.
  
   

• 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
 

Minimum Salary (Hourly Rate): 50.150000

Maximum Salary (Hourly Rate): 88.280000

Salary Admin Plan: MGR