Clinical Data Manager

Guidehouse•Bethesda, MD

3d•$74,000 - $124,000

About The Position

We are currently searching for 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. The Clinical Data Manager oversees data management of multiple complex trials, completes data extraction from electronic medical records and enters in the trial database, reviews data at critical time points, and serves as an internal clinical trial data management expert. This opportunity is a full-time role.

Requirements

Bachelor’s degree.
Four (4) years of experience in extracting data from an EMR and data management.
Experience with clinical/medical terminology required.
Project and timeline management experience is required.
Experience with computer platforms and databases.
Experience with Microsoft Excel for data reporting.
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).
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).
Knowledge of Federal information technology, Biotech or Pharmaceutical Industry, or equivalent comparable background.

Nice To Haves

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.
Strong oral and written communication skills and attention to detail.
Proficient in MS Office Suite.

Responsibilities

Extract data from electronic medical records (EMR) and/or other source documentation; enter in 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.
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 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.

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