Clinical Data Manager

Clinical Data Manager –
Guidehouse

Location:

Bethesda, MD

Salary Range: $74,000 – $124,000 (depends on experience and qualifications)

• Extract data from electronic medical records (EMR) and other source documentation; enter into a clinical trial database following Good Data Management Practices (GDMP).
• Manage NIH Clinical Data Management project timelines on multiple complex protocols or programs.
• Provide guidance on core data management functions including design of the electronic Case Report Form (eCRF), development of edit check functionality, complete user acceptance testing, and provide reporting.
• Oversee clinical data management study deliverables.
• Conduct data quality checks and data reviews.
• Develop protocol‑specific data management plans ensuring alignment with protocol and data quality standards.
• Develop eCRF Completion Guidelines.
• Collaborate and support cross‑functional process initiatives.
• Provide data management support and reporting needs in preparation for and response to continuing reviews, monitoring visits, data safety monitoring board (DSMB) meetings, and audits.
• Participate in clinical research team meetings.
• Extract, grade, and manage adverse events based on protocol specifications and standard operating procedures (SOPs).
• Ensure adherence to project and SOPs, as well as Federal Regulations and ICH GCP in maintaining data integrity and quality throughout a clinical trial.
• Assist with the development, review, and implementation of clinical data management SOPs and processes.
• Evaluate and mitigate risks on protocols and across the program.
• Other duties as assigned.

• Bachelor’s degree
• 2+ years of experience in data management
• Experience with clinical/medical terminology
• Project and timeline management experience
• Experience with computer platforms and databases
• Experience with Microsoft Excel for data reporting

• Working knowledge of GCP and Human Research Subjects Protection guidelines, and regulatory requirements related to clinical development and compliance.
• Strong oral and written communication skills and attention to detail.
• Proficient in MS Office Suite.
• Experience in creating data management tracking systems, error‑checking procedures, and backup procedures to prevent loss of data.
• Experience with clinical trial databases, clinical trial data management systems, and electronic data capture (EDC).
• Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP).
• Knowledge of federal information technology, biotech or pharmaceutical industry, or equivalent comparable background.

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance,  protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities, and any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you require an accommodation, please contact Guidehouse Recruiting at 1‑571‑633‑1711 or via email at Recruitin All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide banking information to a third party purporting to need that information to proceed in the hiring process.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.