Ensure documentation aligns with quality management system (QMS) requirements * Collaborate with ... Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations ...
Ensure documentation aligns with quality management system (QMS) requirements * Collaborate with ... Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations ...
Ensure documentation aligns with quality management system (QMS) requirements * Collaborate with ... Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations ...
Ensure documentation aligns with quality management system (QMS) requirements * Collaborate with ... Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations ...
Ensure documentation aligns with quality management system (QMS) requirements * Collaborate with ... Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations ...
Ensure documentation aligns with quality management system (QMS) requirements * Collaborate with ... Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations ...
Members within our PI project teams wear multiple hats to deliver quality work, including building ... Operational experience in process improvement, operational change management, and/or informatics ...
Members within our PI project teams wear multiple hats to deliver quality work, including building ... Operational experience in process improvement, operational change management, and/or informatics ...
Provides updates on project status and deliverables to Clinical Project Management leads (deliverables may include project status reports, vendor reports, trackers, meeting minutes/action items)
Provides updates on project status and deliverables to Clinical Project Management leads (deliverables may include project status reports, vendor reports, trackers, meeting minutes/action items)
Essex is a biomedical informatics and health information technology-focused consultancy founded in ... Emmes Group is transforming the future of clinical research, bringing the promise of new medical ...
Essex is a biomedical informatics and health information technology-focused consultancy founded in ... Emmes Group is transforming the future of clinical research, bringing the promise of new medical ...
Project Manager - Essex Management (Contingent Role)
Rockville, MD · On-site +1
$133K - $134K/yr
Essex is a biomedical informatics and health information technology-focused consultancy founded in ... Emmes Group is transforming the future of clinical research, bringing the promise of new medical ...
Project Manager - Essex Management (Contingent Role)
Rockville, MD · On-site +1
$133K - $134K/yr
Essex is a biomedical informatics and health information technology-focused consultancy founded in ... Emmes Group is transforming the future of clinical research, bringing the promise of new medical ...
Manage project portfolios for their respective business units. * Assist with project management ... Serve as the informatics/business or clinical application subject matter expert on EHRs or ...
Manage project portfolios for their respective business units. * Assist with project management ... Serve as the informatics/business or clinical application subject matter expert on EHRs or ...
Clinical Research Coordinator
$26 - $34.50/hr
... informatics, data management, quality assurance, and clinical operations support. The Government ... Strong organizational, communication, and project coordination skills * Demonstrated experience ...
Clinical Research Coordinator
$26 - $34.50/hr
... informatics, data management, quality assurance, and clinical operations support. The Government ... Strong organizational, communication, and project coordination skills * Demonstrated experience ...
Clinical Research Coordinator
Bethesda, MD · On-site
$26 - $34.50/hr
... informatics, data management, quality assurance, and clinical operations support. The Government ... Strong organizational, communication, and project coordination skills * Demonstrated experience ...
Quick apply
Clinical Research Coordinator
Bethesda, MD · On-site
$26 - $34.50/hr
... informatics, data management, quality assurance, and clinical operations support. The Government ... Strong organizational, communication, and project coordination skills * Demonstrated experience ...
Clinical Research Coordinator
Bethesda, MD · On-site
$26 - $34.50/hr
... informatics, data management, quality assurance, and clinical operations support. The Government ... Strong organizational, communication, and project coordination skills * Demonstrated experience ...
Clinical Research Coordinator
Bethesda, MD · On-site
$26 - $34.50/hr
... informatics, data management, quality assurance, and clinical operations support. The Government ... Strong organizational, communication, and project coordination skills * Demonstrated experience ...
... Clinical Informatics programs. These roles apply process improvement and business process ... Experience supporting or working on projects associated with federal health agencies such as NIH ...
... Clinical Informatics programs. These roles apply process improvement and business process ... Experience supporting or working on projects associated with federal health agencies such as NIH ...
Perioperative Systems Business Analyst
Baltimore, MD · On-site
$37.75/hr
Responsibilities The Business Analyst assists with the management data and maintenance of business and clinical informatics projects, education projects and competencies within the perioperative ...
Perioperative Systems Business Analyst
Baltimore, MD · On-site
$37.75/hr
Responsibilities The Business Analyst assists with the management data and maintenance of business and clinical informatics projects, education projects and competencies within the perioperative ...
Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do ... The Informatics Sales Specialist team influences bio-informatics data analysis and data management ...
Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do ... The Informatics Sales Specialist team influences bio-informatics data analysis and data management ...
This position has responsibility for Information Technology, Clinical Informatics and Information ... Encourage and emphasizes an effective project management approach and skills development
This position has responsibility for Information Technology, Clinical Informatics and Information ... Encourage and emphasizes an effective project management approach and skills development
Scientific Project Manager (Biomedical Data Coordination)
Rockville, MD · On-site
$52.75 - $71.25/hr
You are comfortable working with scientists, data analysts, informatics professionals ... clinical research. * You are collaborative, adaptable, and able to operate effectively in a fast ...
Scientific Project Manager (Biomedical Data Coordination)
Rockville, MD · On-site
$52.75 - $71.25/hr
You are comfortable working with scientists, data analysts, informatics professionals ... clinical research. * You are collaborative, adaptable, and able to operate effectively in a fast ...
DIRECTOR INFORMATION SYSTEMS
Baltimore, MD · On-site
$69.69 - $89.98/hr
This position has responsibility for Information Technology, Clinical Informatics and Information ... Encourage and emphasizes an effective project management approach and skills development
DIRECTOR INFORMATION SYSTEMS
Baltimore, MD · On-site
$69.69 - $89.98/hr
This position has responsibility for Information Technology, Clinical Informatics and Information ... Encourage and emphasizes an effective project management approach and skills development
Scientific Project Manager (Biomedical Data Coordination)
Rockville, MD · On-site
$52.75 - $71.25/hr
You are comfortable working with scientists, data analysts, informatics professionals ... clinical research. * You are collaborative, adaptable, and able to operate effectively in a fast ...
Scientific Project Manager (Biomedical Data Coordination)
Rockville, MD · On-site
$52.75 - $71.25/hr
You are comfortable working with scientists, data analysts, informatics professionals ... clinical research. * You are collaborative, adaptable, and able to operate effectively in a fast ...
Scientific Project Manager (Biomedical Data Coordination)
Rockville, MD · On-site +1
$90K - $110K/yr
... clinical, translational, or research-focused programs. * You are a natural organizer, task manager ... You are comfortable working with scientists, data analysts, informatics professionals ...
Scientific Project Manager (Biomedical Data Coordination)
Rockville, MD · On-site +1
$90K - $110K/yr
... clinical, translational, or research-focused programs. * You are a natural organizer, task manager ... You are comfortable working with scientists, data analysts, informatics professionals ...
Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do ... The Informatics Sales Specialist team influences bio-informatics data analysis and data management ...
Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do ... The Informatics Sales Specialist team influences bio-informatics data analysis and data management ...
Clinical Informatics Project Manager information
What is a clinical informatics project manager?
What is the difference between Clinical Informatics Project Manager vs Clinical Analyst?
| Aspect | Clinical Informatics Project Manager | Clinical Analyst |
|---|---|---|
| Credentials | Typically requires a degree in health informatics, healthcare, or related field; certifications like CPHIMS are common | Often holds a degree in health informatics, nursing, or healthcare; certifications like CPHIMS or RHIA may be preferred |
| Work Environment | Manages projects across healthcare settings, coordinating teams and resources | Analyzes clinical data, supports system implementation, and improves workflows |
| Employer & Industry | Hospitals, health systems, healthcare IT companies | Hospitals, clinics, healthcare organizations, and IT vendors |
The Clinical Informatics Project Manager focuses on leading and coordinating healthcare IT projects, ensuring timely delivery and stakeholder communication. In contrast, the Clinical Analyst primarily analyzes clinical data and supports system optimization. Both roles require healthcare and informatics knowledge but differ in scope and responsibilities.
What are the key skills and qualifications needed to thrive as a clinical informatics project manager, and why are they important?
How does a clinical informatics project manager typically collaborate with clinical staff and IT teams during project implementation?
- Pharmacy Informatics Specialist
- Senior Clinical Informatics Specialist
- Contract Clinical Informatics Specialist
- Clinical Informatics Specialist
- Cerner Pharmacy Informatics
- Health Informatics Consultant
- Freelance Clinical Informatics Specialist
- Entry Level Health Informatics Specialist
- No Experience Informatics Nurse
- Health Informatics Analyst

Full-time
Medical, Life, Retirement, PTO
Re-posted 4 days ago
Job description
The Clinical Lab Information Specialist plays a critical role in supporting laboratory technology initiatives with a strong emphasis on User Acceptance Testing (UAT), system validations, and regulatory compliance documentation. This position serves as a key liaison between laboratory operations, IT, quality, and external vendors to ensure that laboratory systems are implemented, validated, and maintained in accordance with regulatory standards and business needs. This position will be fully onsite at our Frederick, MD location.
The ideal candidate combines deep clinical laboratory knowledge with expertise in system implementation, validation methodologies, and regulatory documentation within a highly controlled environment (e.g., CLIA, CAP, FDA, GxP).
Main Duties & Responsibilities:
Essential duties include but are not limited to:
UAT Leadership & Execution
- Lead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologies
- Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirements
- Partner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use cases
- Facilitate defect tracking, triage, and resolution in collaboration with IT and vendors
- Ensure traceability between requirements, test cases, and outcomes
System Validation & Compliance
- Plan and execute system validation activities in accordance with regulatory standards (e.g., GxP, FDA 21 CFR Part 11, CLIA, CAP)
- Author and/or review validation deliverables, including:
- Validation Plans (VP)
- Requirements Specifications (URS/FRS)
- Risk Assessments
- IQ/OQ/PQ protocols and reports
- Traceability matrices
- Ensure systems are audit-ready and compliant with internal quality systems and external regulatory expectations
- Support audit and inspection activities, including responses and corrective actions
Regulatory Documentation & Quality Support
- Develop and maintain SOPs, work instructions, and supporting documentation related to laboratory systems and processes
- Ensure documentation aligns with quality management system (QMS) requirements
- Collaborate with Quality Assurance to maintain compliance and support continuous improvement initiatives
- Maintain document control and versioning in accordance with regulatory standards
Business Analysis & Stakeholder Engagement
- Gather, analyze, and document business and functional requirements from laboratory stakeholders
- Translate complex laboratory workflows into system requirements and technical specifications
- Serve as a liaison between laboratory operations, IT, vendors, and quality teams
- Facilitate workshops, meetings, and process mapping sessions
System Implementation & Optimization
- Support system implementation, upgrades, and enhancements across laboratory platforms
- Identify opportunities to improve efficiency, data integrity, and compliance through system optimization
- Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations
Education & Experience:
Minimum Education & Experience:
- Bachelor's Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field required
- 5-8 years of related experience in clinical laboratory operations, laboratory informatics, or business analysis
- Strong experience with laboratory systems (LIS, LIMS, middleware, instrument interfaces)
- Demonstrated expertise in UAT coordination and execution
- Hands-on experience with system validation in regulated environments (GxP, CLIA, CAP, FDA)
- Experience authoring validation and regulatory documentation
Preferred Education & Experience (optional):
- Experience with specific LIS platforms (e.g., Epic Beaker, SCC Soft, Sunquest, Cerner Millennium)
- Familiarity with data standards (HL7, interfaces, instrument connectivity)
- Experience in audit/inspection readiness and regulatory submissions
- Knowledge of electronic document management systems (eDMS) and change control processes
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$83,200-$124,800 USD
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
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About Precision Medicine Group
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Bethesda, MD, US
Year founded
2012