Clinical Project Manager II - Essex Management

Emmes Group•Rockville, MD

9h•Remote

About The Position

The Clinical Project Manager (CPM) II is responsible for delivering clinical and research initiatives that support complex IT and life sciences programs. This role leads cross-functional project teams across technology implementations, clinical study operations, data integrations, and regulatory-compliant systems. The CPM II brings hands-on study management experience spanning participant enrollment, informed consent, data collection, and research participant engagement — ensuring that operational execution aligns with both scientific objectives and compliance requirements. The CPM II cultivates collaborative relationships with project and client stakeholders, coordinating across teams to ensure study goals are achieved and deliverable timelines are met. This role drives implementation strategy, maintains operational plans and documentation, and continuously optimizes study processes to support high-quality clinical research delivery. The CPM II is expected to maintain current awareness of industry best practices and emerging trends in study management, actively contributing that knowledge to strengthen Essex's methodologies and commitment to continuous improvement.

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
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
Experience with dashboards, data systems, or study management tools; requirements gathering and user acceptance testing experience preferred
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

Nice To Haves

Experience with oncology and/or rare disease studies is desirable
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))

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