Guidehouse · 4 hours ago
Clinical Data Manager
US - MD, Bethesda
Full-time
Onsite
Entry, Mid Level
$56K/yr - $94K/yr
2+ years expGuidehouse is seeking a Clinical Data Manager to support the National Institutes of Health (NIH). The role involves overseeing data management for clinical trials, ensuring data integrity, and collaborating with various stakeholders to maintain high data quality standards.
AdviceConsultingManagement Consulting
No H1B
Security Clearance Required
Responsibilities
Extract data from electronic medical records/source documentation and enter in clinical trial database following good data management practices
Manage NIH Clinical Data Management project timelines on multiple complex protocols or programs
Provide guidance on core data management functions including eCRF design, edit check development, user acceptance testing, and reporting
Responsible for the oversight of 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 and maintain 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 SOPs
Ensure adherence to project and standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical trial
Evaluate and mitigate risks on protocols and across the program
Qualification
Required
Bachelor's Degree in Life Sciences, Computer Science, or related studies
A minimum of TWO (2) years' experience in extracting data from an EMR and data management in support of clinical trials
Experience with clinical/medical terminology required
Project management experience. Must have experience managing timelines
Experience in creating data management tracking systems, error-checking procedures, and back-up procedures to prevent loss of data
Knowledge of Federal information technology, Biotech or Pharmaceutical Industry, or equivalent comparable background
Experience with clinical trial databases, clinical trial data management systems, and electronic data capture (EDC)
Working knowledge of GCP and Human Research Subjects Protection guidelines, as well as regulatory requirements relating to clinical development and compliance with safety, ethical, legal, and regulatory standards
Demonstrated current understanding of the regulations as they relate to clinical trial data management systems and activities; demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
Proficient in using Microsoft Excel for data reporting
Good communication skills
Must be able to obtain and maintain a Federal or DoD 'public trust'; candidates must obtain approved adjudication of their public trust prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred
Preferred
Previous experience with NIH preferred
Benefits
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
Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus
Company
Guidehouse
Guidehouse offers consulting services for public and commercial markets with expertise in management, technology, and risk consulting.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$0.75MKey Investors
Mission Daybreak
2023-11-06Acquired
2023-02-16Grant· $0.75M
Leadership Team
Scott McIntyre
Chairman and CEO
Alicia Harkness
Partner
Recent News
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