Sr. Project Leader (Fixed Term Engagement)

Sr. Project Leader

Notice to Applicants: This engagement is presently forecasted to run till the end of the year. We'll reevaluate the duration with new information presenting itself.

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 workstreams.
• 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, consortia partners, and external collaborators.
• Participate in investigator meetings, scientific advisory boards, and expert panels.
• Foster collaborative relationships that advance the mission of assigned research programs.
• Ensure continuous protection of human subjects in accordance with federal policy, GCP, and corporate and institutional standards.
• Review safety data, oversee Data and Safety Monitoring Board (DSMB) interactions, and guide risk/benefit assessments.
• Escalates persistent issues and coordinates corrective action plans when needed.
• Selects and evaluates subcontractors and vendors in alignment with project needs and corporate standards.
• Negotiates scopes of work, deliverables, timelines, and pricing in collaboration with contract teams.
• Monitors vendor performance against contractual obligations and project milestones.
• Oversees development and approval of vendor Statements of Work (SOWs) and contract modifications.
• Represents the project in Corporate meetings (e.g., project reviews), with Executive leaders, as applicable.
• Uses key performance metrics to successfully execute the project scope.
• Mentors project staff and supports staff development; may be responsible for the development of new Project Leaders.
• Provide performance related feedback to department managers for project staff.
• Models Emmes culture of integrity, accountability, collaboration, innovation, and perseverance across internal and external teams.
• Promotes and implements relevant corporate initiatives as directed.
• Leads or contributes to the development of operational strategy, budget, and proposal content for new business opportunities, as assigned.
• Develops, maintains, and acquires approval of budgets and statement of work documents and subsequent modifications prior to distribution to clients, as well as approvals for invoices and subagreements.
• Performs other duties as assigned
• Complies with all policies and standards

• Bachelor's Degree Required or
• Master's Degree Preferred or
• PhD Preferred
• 12+ Years + Bachelor's with empirical knowledge of the key accountabilities/duties/responsibilities for the position with a typical tenure of at least 5 years project management experience in a research environment. Required or
• 9 years + Master's with empirical knowledge of the key accountabilities/duties/responsibilities for the position with a typical tenure of at least 5 years project management experience in a research environment. Preferred or
• 6 years + PhD with empirical knowledge of the key accountabilities/duties/responsibilities for the position with a typical tenure of at least 5 years project management experience in a research environment. Preferred
• Project Delivery Track Record: Demonstratable track record of successfully delivering complex/high-priority clinical trials or clinical research projects within the agreed time, quality, and budget. Experience in federally-funded research is preferred. High
• Clinical Research Knowledge: Demonstrated working knowledge of the principles of clinical research management and operations. High
• Problem-Solving: Demonstrated strong problem-solving and analytical skills, combined with sound business and ethical judgment. High
• Communication: Excellent verbal and written communication skills for client, team, and scientific interactions. High
• Leadership & Teamwork: Ability to work proactively and effectively, with creative problem-solving and collaboration skills. Highly motivated with the ability to work independently and as part of a multi-disciplinary team. Ability to supervise, mentor, and support lower-level project leaders and staff.
• Project Management: Strong cross-functional project management and time management skills.
• Therapeutic Expertise (Preferred): Broad understanding of a therapeutic area, clinical trial design, and/or process expertise to influence and execute project decisions.

If you're looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.

CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/