Emmes Group is transforming the future of clinical research, bringing the promise of new medical discoveries closer within reach for patients. The Clinical Project Manager II is responsible for delivering clinical and research initiatives that support complex IT and life sciences programs, leading cross-functional project teams and ensuring operational execution aligns with scientific objectives and compliance requirements.
Responsibilities:
- Lead the end-to-end execution of clinical trials and observational studies, from protocol design through final clinical study report, applying best practices across all project phases — initiation, planning, execution, monitoring, and close-out
- Develop and maintain integrated, cross-functional project plans to support study tracking, milestone management, and oversight across all workstreams
- Anticipate potential barriers, identify project risks, and propose mitigation strategies; adhere to established governance structures and processes for assigned projects
- Lead and coordinate cross-functional study team activities, including patient engagement, clinical monitoring, data management, biostatistics, and safety, to ensure proper conduct and timely study completion
- Collaborate with internal teams, contractors, and vendors — including functions such as finance, R&D, regulatory, and marketing — to align efforts and achieve study goals and objectives
- Ensure communication plans are in place and maintained to support effective information flow among all study and project stakeholders
- Contribute to database design and development with a focus on data abstraction, report generation, and quality assurance to support effective data monitoring
- Maintain compliance with Good Clinical Practice (GCP), regulatory requirements, and applicable Essex and client policies and procedures
- Participate in quality assurance activities to ensure deliverables meet contractual requirements and key performance indicators are monitored and achieved
- Track and manage adherence to budget, scope, and schedule requirements throughout the project lifecycle
- Organize and facilitate project meetings, including scheduling, preparation of materials, meeting minutes, and follow-up on action items
- Prepare monthly status reports and project-specific documentation in accordance with reporting requirements
- Complete required Essex and client training and maintain ongoing awareness of relevant policies to ensure continuous compliance
Requirements:
- Bachelor's degree in public health, life sciences, clinical research, or a related field (Master's preferred); or a commensurate combination of education and experience
- 3–5+ years of experience in clinical research operations, study implementation, clinical data management, or a related discipline
- Familiarity with IRB processes, regulatory requirements, and clinical research compliance standards
- Experience with oncology and/or rare disease studies
- Proficiency in project management methodologies, with the ability to work with minimal guidance from program or project leadership
- Proficient in Microsoft Office Suite and project management and visualization tools, including MS Project, MS Power Suite, Confluence, Jira, and GitHub
- Skilled in identifying, analyzing, and mitigating project risks, with confidence to escalate issues appropriately to project teams and Essex leadership
- Knowledge of and experience applying quality assurance and quality management practices
- Strong leadership, facilitation, and team motivation skills, with the ability to guide cross-functional and matrixed project teams
- Excellent verbal and written communication skills; a focused and engaged communicator with internal teams, client stakeholders, and research participants
- Skilled in stakeholder management — building and maintaining productive relationships with Essex colleagues and client contacts to ensure expectations and business needs are met
- Strong organizational skills with the ability to manage multiple priorities, create detailed project plans, and maintain timelines and schedules
- Demonstrated experience developing SOPs, implementation plans, and operational documentation
- Competent in making timely, informed decisions and adapting effectively to evolving priorities or project conditions
- Ability to engage directly with patients and families with empathy, professionalism, and sensitivity to the stressors inherent in clinical research participation
- Customer-focused and committed to delivering high-quality service and ensuring client satisfaction
- PMP, CAPM, or equivalent project management certification
- Directly relevant experience in one or more of the following: pharma/biopharma GxP or GCP environments, 21 CFR Part 11 regulated systems, federal health IT contracting (e.g., HHS, NIH, VA, DoD), or clinical informatics and EHR implementations in regulated settings
- Experience supporting projects associated with federal health agencies (e.g., National Institutes of Health (NIH), National Cancer Institute (NCI))