Clinical Project Manager II

CAMRIS; Rockville (MD); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

401(k) with employer match

Tuition reimbursement

Paid time off

Job summary

CAMRIS International seeks a Clinical Project Manager II to support NIH/NCI initiatives in Rockville, MD. The role emphasizes clinical trial reporting, biomedical informatics, data management, and operations, with engagement across CTRP/CTRO, PRS, and EVS terminology.

You will lead cross-functional teams, manage schedules and budgets, and ensure regulatory reporting and quality assurance, working with government and academic partners. The position is forecasted pending contract award.

Qualifications

• Bachelor's degree in clinical research, life sciences, health sciences, biomedical informatics, public health, IT, or related.
• Minimum 5 years of experience in clinical operations, data management, or biomedical informatics.

Responsibilities

• Lead planning, execution, monitoring, reporting, and coordination of clinical trial and biomedical informatics activities.
• Manage project schedules, scope, risks, issues, deliverables, budgets, and stakeholder communications.
• Coordinate cross-functional clinical, scientific, technical, regulatory, and data-management teams.
• Support CTRP/CTRO operations, including trial registration, status updates, QA, and SOP development.
• Apply project-management best practices across initiation, planning, execution, control, and closeout.

Skills

Project management

Stakeholder management

Regulatory reporting

Clinical trial lifecycle

Cross-functional coordination

Education

Bachelor's degree in clinical research or related field

Tools

NCI CTRP/CTRO

NCI ClinicalTrials.gov PRS

NCI Thesaurus/EVS

Job description

Overview

We are seeking a Clinical Project Manager II to support the National Institutes of Health (NIH), National Cancer Institute (NCI) in Rockville, MD. This role will support clinical trial reporting, biomedical informatics, data management, and clinical research operations, with particular emphasis on NCI CTRP/CTRO, ClinicalTrials.gov PRS, and NCI semantic/terminology services. CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.*This is a forecasted position, and it is contingent upon contract award.

Responsibilities

• Lead planning, execution, monitoring, reporting, and coordination of clinical trial and biomedical informatics activities.
• Manage project schedules, scope, risks, issues, deliverables, budgets, and stakeholder communications.
• Coordinate cross-functional clinical, scientific, technical, regulatory, and data-management teams.
• Support NCI CTRP/CTRO operations, including clinical trial registration, abstraction, coding, amendments, status updates, accrual reporting, quality assurance, and SOP development.
• Support the NCI ClinicalTrials.gov Protocol Registration and Results System (PRS) account, including trial registration, updates, results reporting, and FDAAA compliance activities.
• Apply and support NCI Thesaurus and Enterprise Vocabulary Services (EVS) terminology used in clinical trial abstraction and coding, including coordination of new terminology requests.
• Work with NCI stakeholders and organizations such as CBIIT, CCCT, CTEP, DCP, NCI-designated Cancer Centers, and other contractor teams.
• Facilitate meetings, training, communications, and operational coordination across project stakeholders.
• Apply project-management best practices across project initiation, planning, execution, control, and closeout.

Qualifications

• Bachelor's degree in clinical research, life sciences, health sciences, biomedical informatics, public health, IT, or a related discipline.
• Minimum 5 years of experience in clinical operations, clinical data management, clinical research, biomedical informatics, or a related field.
• Demonstrated project or program management experience supporting clinical or biomedical programs.
• Strong understanding of clinical trial lifecycle activities, protocol data, regulatory reporting, and data quality.
• Strong written, verbal, organizational, and stakeholder-management skills.
• Experience working with government, scientific, clinical, or technical stakeholders.
• Experience with clinical trial abstraction and coding.
• Knowledge of FDAAA registration and results-reporting requirements.
• Direct NCI experience, particularly with CTRP, CTRO, CBIIT, or related NCI clinical research programs is strongly preferred.
• Hands-on experience with the NCI ClinicalTrials.gov PRS account.
• Experience with NCI-sponsored trial registration, amendments, updates, and results reporting.
• Experience using NCI Thesaurus, EVS, caDSR, Common Data Elements, metadata, vocabularies, or ontologies.
• Familiarity with CTEP, DCP, CCCT, or NCI-designated Cancer Centers.
• PMP, CCRP, CCRA, ACRP, SOCRA, or similar certification is preferred.

Physical Requirements

The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

Physical Demands

Constantly conduct sedentary work that primarily involves sitting/standing. Occasionally conduct light work that includes moving objects up to 20 pounds. Occasionally push or pull less than 25 pounds. Rarely reach above shoulder level. Constantly use both hands. Occasionally stand or walk for more than 25 minutes. Rarely bend, reach, or twist repeatedly. Rarely kneel, squat, or stoop. Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

Occasionally move about to accomplish tasks or move from one worksite to another. Constantly communicate with others to exchange information. Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

Constantly work in environments where no adverse environmental conditions are expected.

CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Benefits

• medical, dental, and vision insurance for individuals and families
• FSAs
• HSA
• life and AD&D insurance
• short- and long-term disability
• legal services
• voluntary hospital indemnity
• critical illness and accident insurances
• EAP
• pet insurance
• 401(k) with employer match and Roth option
• tuition and professional reimbursement
• public transportation support in the DMV area
• a referral bonus program
• vacation with tenure-based increases
• PTO
• 11 paid holidays
• paid bonding leave
• paid supplemental short-term disability

Background Check

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.