Clinical Data Manager

Job Family:

Medical Data Analyst & Researcher (Digital)

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

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:

• 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

  
  What Would Be Nice To Have:

• Previous experience with NIH preferred.  

The annual salary range for this position is $56,000.00-$94,000.00. 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