Clinical Project Manager II - Essex Management

Overview

Job Title: Clinical Project Manager II - Essex Management

Notice to Candidates: Employment in this position is expressly contingent upon Essex Management’s receipt of a contract award from the Federal Government.

Location: US Remote

This position supports "Essex, an Emmes Company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discoveries closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

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.

Responsibilities

Study & Project Management

• 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
  
  

Team & Stakeholder Coordination

• 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
  
  

Data, Compliance & Quality

• 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
  
  

Operations & Reporting

• 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
  
  

Qualifications

Education & Experience

• 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 is desirable
  
  

Technical Skills

• 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
  
  

Core Competencies

• 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
  
  

Preferred Qualifications

• 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))
  
  

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment
  
  

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.