Clinical Research Spec

The ERP (External Research Program)/ISR (Investigator Sponsored Research) Project Manager is responsible for managing ISR studies from submission intake through study close-out, ensuring timely, compliant, and high-quality execution. This role serves as the primary point of contact for external investigators and internal cross-functional partners, coordinating submission activities, portfolio and ERP board presentations, and study start-up processes including shipping requests and financial forecasting. During active study management, the ERP Project Manager drives cross-functional collaboration, supports regional partners, and partners with the contracts team during contract negotiations. At study completion, the role supports publication review and, where applicable, data analysis and interpretation to ensure study deliverables are completed in accordance with company policies and regulatory requirements.

What are the top 3 things you are looking for in a candidates experience:

• Hands-on experience with Investigator Sponsored Research (ISR) / External Research Program (ERP) Experience supporting ISR from either the Sponsor (industry) and/or Site perspective. This includes familiarity with study submission, review processes, study conduct, and closeout activities within an ERP framework.
• Strong project management experience in a clinical research environment Demonstrated ability to manage multiple studies or workstreams simultaneously, including tracking timelines, coordinating deliverables, supporting portfolio or board reviews, and managing financial forecasting and payments related to research projects.
• Excellent communication and stakeholder management skills Proven ability to manage complex communication networks, working cross?functionally within a large organization (e.g., clinical, finance, contracts, regional partners) and externally with physicians, investigators, and site staff. Clear, proactive, and professional communication is critical.
  
  

Education Required: Bachelors Degree

Years’ Experience Required: at least 1 year Investigator Sponsored Research (ISR) experience.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience