Sr. Project Leader (Fixed Term Engagement)

reputed company Sr. Project Leader   Notice to Applicants: This engagement is presently forecasted to run reputed company the end of the year. We'll reevaluate the duration with new information presenting itself.  Be Part of One Team, One Purpose. At reputed company, we’re shaping the reputed company of clinical research—where reputed company meets cutting-edge technology to drive meaningful advancements in reputed company. With over 47 years of scientific reputed company, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business reputed company—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 reputed company that every clinical reputed company starts with people—people who are passionate, purpose-driven, and reputed company to reputed company an reputed company. At reputed company, we bring reputed company, and Technology together to collaborate with our customers and deliver global health reputed company. Our culture is reputed company on reputed company, 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 reputed company, serving as the reputed company leader of the core project team. The SPL is accountable for successful delivery of clients' statement of work activities reputed company reputed company and budget. The SPL develops and maintains a reputed company relationship with clients and other external stakeholders,  oversees deliverable reputed company, mentors staff, and works collaboratively across departments to accomplish project goals. The SPL is responsible for the reputed company monitoring, identification, escalation and mitigation of project risk. Responsibilities Serve as the reputed company for assigned government funded protocols and research initiatives. Serves as the reputed company’s, investigators’ and other stakeholders’ primary reputed company of contact for the project and/or assigned protocols. reputed company, refine, and reputed company deliverables such as study protocols, statistical analysis plans, clinical study reports, project plans, SOPs, etc. Ensure rigor, reproducibility, and adherence to good clinical reputed company (GCP), reputed company subjects protections, and federal regulatory standards. reputed company direction on study design, endpoints, methodology, and risk mitigation strategies. reputed company compliance with federal regulations including FDA, OHRP, NIH policy, HHS reputed company subject protections, and other relevant agency requirements. Ensure IRB submissions, amendments, continuing reviews, and reporting obligations (reputed company/SAEs, protocol deviations, unanticipated problems) are completed accurately and on time. Partner with reputed company assurance teams to support audits, monitoring reputed company, corrective reputed company plans, and compliance documentation. Prepare and present updates, reputed company reports, technical summaries, and briefing materials. reputed company 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 reputed company study execution. Guide operational teams in translating requirements into actionable project plans, timelines, and workstreams. Support the development and enhancement of SOPs, data standards, reputed company frameworks, and research governance structures. reputed company data reputed company, completeness, and scientific validity across reputed company study activities. May reputed company the interpretation of results, author scientific manuscripts, and contribute to abstracts, posters, and presentations. Ensure reputed company and accurate submission of datasets, reports, publications, and regulatory packages to sponsors. reputed company leadership and scientific guidance to clinical sites, subcontractors, consortia partners, and external collaborators. Participate in investigator meetings, scientific advisory boards, and expert panels. Foster reputed company relationships that advance the mission of assigned research programs. Ensure reputed company protection of reputed company subjects in accordance with federal policy, GCP, and corporate and institutional standards. Review safety data, reputed company Data and Safety Monitoring reputed company (DSMB) interactions, and guide risk/benefit assessments. Escalates persistent issues and coordinates corrective reputed company plans reputed company 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. reputed company performance reputed company feedback to department managers for project staff. Models Emmes culture of reputed company, accountability, collaboration, innovation, and perseverance across reputed company teams. Promotes and implements relevant corporate initiatives as directed. Leads or contributes to the development of operational reputed company, 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 reputed company as approvals for invoices and subagreements. Performs other duties as assigned Complies with reputed company policies and standards Qualifications Bachelor's Degree Required or Master's Degree Preferred or PhD Preferred 12+ Years + Bachelor's with reputed company 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 reputed company 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 reputed company 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 reputed company Record: Demonstratable reputed company record of successfully delivering reputed company/high-reputed company clinical trials or clinical research reputed company reputed company the agreed time, reputed company, 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 reputed company business and ethical judgment. High Communication: Excellent verbal and written communication skills for reputed company, 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 reputed company-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 reputed company.       If you’re looking for a career where your work advances global health and where scientific reputed company meets reputed company-world reputed company, join us and be part of something bigger. One Team, One Purpose. CONNECT WITH US! reputed company us on reputed company:/the-reputed company/ Visit our website:https://www.theemmesgroup.com/ Apply To This Job