Sr. Project Leader

Overview

Sr. Project Leader
Be Part of One Team, One Purpose. At Emmes Group
, we’re shaping the future of clinical research—
where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence
, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units—
Emmes, a full-service CRO
, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people
—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation
, ensuring that every challenge is met with perseverance and accountability. The Senior Project Leader (SPL) is critical to the successful conduct of government-sponsored clinical research projects, serving as the matrix leader of the core project team. The SPL is accountable for successful delivery of clients' statement of work activities within timeline and budget. The SPL develops and maintains a positive relationship with clients and other external stakeholders, oversees deliverable quality, mentors staff, and works collaboratively across departments to accomplish project goals.

The SPL is responsible for the continuous monitoring, identification, escalation and mitigation of project risk.

• Serve as the lead for assigned government funded protocols and research initiatives.
• Serves as the client’s, investigators’ and other stakeholders’ primary point of contact for the project and/or assigned protocols.
• Develop, refine, and oversee deliverables such as study protocols, statistical analysis plans, clinical study reports, project plans, SOPs, etc.
• Ensure rigor, reproducibility, and adherence to good clinical practice (GCP), human subjects protections, and federal regulatory standards.
• Provide direction on study design, endpoints, methodology, and risk mitigation strategies.
• Oversee compliance with federal regulations including FDA, OHRP, NIH policy, HHS human subject protections, and other relevant agency requirements.
• Ensure IRB submissions, amendments, continuing reviews, and reporting obligations (AEs/SAEs, protocol deviations, unanticipated problems) are completed accurately and on time.
• Partner with quality assurance teams to support audits, monitoring visits, corrective action plans, and compliance documentation.
• Prepare and present updates, progress reports, technical summaries, and briefing materials.
• Provide subject matter expert input to stakeholders on emerging data, operational risks, and scientific considerations.
• Collaborate with cross functional departments—clinical operations, data management, biostatistics, regulatory, project management to ensure integrated and high quality study execution.
• Guide operational teams in translating requirements into actionable project plans, timelines, and work streams.
• Support the development and enhancement of SOPs, data standards, quality frameworks, and research governance structures.
• Oversee data quality, completeness, and scientific validity across all study activities.
• May lead the interpretation of results, author scientific manuscripts, and contribute to abstracts, posters, and presentations.
• Ensure timely and accurate submission of datasets, reports, publications, and regulatory packages to sponsors.
• Provide leadership and scientific guidance to clinical sites, subcontractors,…