Clinical Data Manager
Clinical Data Manager
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$ 56000 - 94000
1 Vacancy
Job Description
Job Family:
Medical Data Analyst & Researcher (Digital)
Travel Required:
Clearance Required:
What You Will Do:
We are currently searching for a Clinical Data Manager to support the National Institutes of Health (NIH). The Clinical Data Manager provides subject matter expertise for clinical trial data in support of NIH research initiatives and oversees data management of multiple complex trials completes data extraction from the electronic medical records and entry in the trial database reviews data at critical time points and serves as an internal clinical trial data management expert. This is a full-time opportunity supporting the office located in Bethesda MD.
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.
What You Will Need:
Bachelors Degree in Life Sciences Computer Science or related studies.
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.
Must have experience managing timelines.
Experience in creating data management tracking systems error-checking procedures and back-up procedures to prevent loss of data.
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
Have a a strong understanding of Good Clinical Data Management Practices (GCDMP).
Proficient in using Microsoft Excel for data reporting.
What Would Be Nice To Have:
Project management experience
Knowledge of Federal information technology Biotech or Pharmaceutical Industry or equivalent comparable background.
Previous experience with NIH preferred.
Good communication skills.
#LI-NDI
The annual salary range for this position is $56000.00-$94000.00. Compensation decisions depend on a wide range of factors including but not limited to skill sets experience and training security clearances licensure and certifications and other business and organizational needs.
What We Offer:
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.
Benefits include:
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 and ID theft protection etc.)
Position may be eligible for a discretionary variable incentive bonus
About Guidehouse
Guidehouse is an Equal Opportunity EmployerProtected Veterans Individuals with Disabilities or 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.
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Required Experience:
Manager
Employment Type
Full-Time
