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Purpose:

The New Development team at UPMC Enterprises is seeking a highly motivated Real-World Data Scientific Program Manager, Enterprises to lead and coordinate interdisciplinary real-world data (RWD) collaborations between UPMC and industry. This role is responsible for managing real world data projects, ensuring alignment with strategic goals, facilitating communication between stakeholders, and overseeing project timelines and deliverables. The ideal candidate will have a strong scientific background, excellent project management skills, and experience in fostering partnerships with industry.

Responsibilities:

+ Project Management & Coordination

+ Develop and manage project plans, timelines, and milestones for real world data collaborations, including RWD studies.

+ Coordinate and facilitate meetings and communications between Department Subject Matter Experts (SMEs), RWD teams, industry partners, and sponsors.

+ Track project progress, identify risks, and implement mitigation strategies to ensure timely completion of deliverables.

+ Provide timely follow-ups, issue resolution, and status updates, escalating problems when necessary.

+ Work collaboratively with research teams to maintain compliance with institutional and sponsor requirements.

+ RWD and Clinical Study Management

+ Closely collaborate with the team to support study planning and execution.

+ Assist in the regulatory review, and submission of clinical study documentation.

+ Serve as the liaison between investigators, sponsors, and Institutional Review Boards (IRB) on all regulatory matters.

+ Participate in sponsor meetings, research discussions, and conferences, ensuring effective knowledge exchange.

+ Partnership & Collaboration

+ Assist in the negotiation and management of contracts and funding agreements.

+ Identify opportunities for new industry collaborations.

+ Work as an effective and collaborative team member, ensuring productive interactions across stakeholders.

+ Regulatory & Compliance Expertise

+ Act as a resource for questions related to regulations affecting a sponsored clinical trials, ensuring adherence to ethical and legal standards.

+ Facilitate resolution of regulatory and compliance issues by communicating with internal and external regulatory experts.

+ Ensure that projects comply with relevant federal, state, and institutional research policies.

+ Financial & Administrative Management

+ Assist in budget development and resource allocation for real world data initiatives.

+ Support funding proposals and regulatory reporting.

+ Maintain records and documentation related to project approvals, funding, and compliance.

+ PhD or Master's degree in a scientific discipline (e.g., life sciences, engineering, biotechnology, chemistry) required.

+ Minimum of 3 years of experience in project management, clinical research, or regulatory affairs required.

+ Proven experience with Real-World Data (RWD) studies and clinical trial management.

+ Strong understanding of regulatory frameworks, including IRB requirements, FDA regulations, and research ethics.

+ Excellent project management, organizational, and problem-solving skills.

+ Effective communication and interpersonal skills to manage diverse stakeholders.

+ Project Management Professional (PMP) or similar certification preferred.

+ Experience working in both academic and industry environments preferred.

+ Knowledge of technology transfer, commercialization, and funding mechanisms preferred.

+ Familiarity with regulatory submissions, such as IND, IDE, and compassionate/emergency use applications preferred. **Licensure, Certifications, and Clearances:** **UPMC is an Equal Opportunity Employer/Disability/Veteran**