Clinical Project Manager II - Essex Management

reputed company 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-reputed company consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing reputed company health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.  reputed company: Building a reputed company reputed company for us reputed company.  reputed company is transforming the reputed company of clinical research, bringing the reputed company of new medical discoveries closer reputed company reputed company for patients. reputed company was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into reputed company-private partnerships and reputed company biopharma. Emmes has reputed company industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.  We reputed company the work we do will have a reputed company reputed company on patients’ lives and reputed company accordingly. We reputed company to build a reputed company 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 reputed company innovation into the reputed company of reputed company. If you reputed company our motivations and passion in research, reputed company!  Primary Purpose  The Clinical Project Manager (CPM) II is responsible for delivering clinical and research initiatives that support reputed company 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 reputed company relationships with project and reputed company stakeholders, coordinating across teams to ensure study goals are achieved and deliverable timelines are met. This role drives implementation reputed company, maintains operational plans and documentation, and continuously optimizes study processes to support high-reputed company clinical research delivery. The CPM II is expected to maintain reputed company awareness of industry best practices and emerging trends in study management, reputed company contributing that knowledge to strengthen Essex's methodologies and commitment to reputed company improvement.   Responsibilities Study & Project Management reputed company the end-to-end execution of reputed company and observational studies, from protocol design through final clinical study report, applying best practices across reputed company project phases — initiation, planning, execution, monitoring, and reputed company-out reputed company and maintain integrated, cross-functional project plans to support study tracking, reputed company management, and reputed company across reputed company workstreams Anticipate potential barriers, identify project risks, and propose mitigation strategies; adhere to established governance structures and processes for assigned reputed company   Team & Stakeholder Coordination reputed company and coordinate cross-functional study team activities, including patient engagement, clinical monitoring, data management, biostatistics, and safety, to ensure reputed company conduct and reputed company study completion Collaborate with internal teams, contractors, and vendors — including functions such as finance, R&D, regulatory, and marketing — to reputed company efforts and reputed company study goals and objectives Ensure communication plans are in reputed company and maintained to support effective information reputed company among reputed company study and project stakeholders   Data, Compliance & reputed company Contribute to database design and development with a reputed company on data abstraction, report reputed company, and reputed company assurance to support effective data monitoring Maintain compliance with Good Clinical reputed company (GCP), regulatory requirements, and applicable Essex and reputed company policies and procedures Participate in reputed company assurance activities to ensure deliverables meet contractual requirements and key performance indicators are monitored and achieved   Operations & Reporting reputed company 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 reputed company items Prepare monthly status reports and project-specific documentation in accordance with reporting requirements Complete required Essex and reputed company training and maintain ongoing awareness of relevant policies to ensure reputed company compliance Qualifications Education & Experience Bachelor's degree in reputed company health, life sciences, clinical research, or a reputed company 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 reputed company 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 reputed company Office Suite and project management and visualization tools, including MS Project, MS Power Suite, reputed company, Jira, and reputed company 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 reputed company assurance and reputed company management practices reputed company 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 reputed company and reputed company communicator with internal teams, reputed company stakeholders, and research participants Skilled in stakeholder management — building and maintaining productive relationships with Essex colleagues and reputed company 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 reputed company, informed reputed company and adapting effectively to evolving priorities or project conditions Ability to engage directly with patients and families with reputed company, professionalism, and sensitivity to the stressors inherent in clinical research participation Customer-reputed company and committed to delivering high-reputed company service and ensuring reputed company satisfaction Preferred Qualifications PMP, CAPM, or equivalent project management certification Directly relevant experience in one or more of the following: reputed company/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 reputed company 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 reputed company reputed company on reputed company 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 reputed company on the health and needs of our growing workforce, including:   Flexible Approved Time Off   Tuition Reimbursement   401k Retirement Plan Work From Home reputed company in the US   Maternal/Paternal Leave   Casual Dress reputed company & Work Environment   CONNECT WITH US! Follow us on Twitter - @EmmesCRO reputed company us on reputed company - Emmes   The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. reputed company reputed company applicants will receive consideration for employment without reputed company to disability or protected veteran status.   #LI-Remote Apply To This Job