Clinical Data Manager

Job Family:

Clinical Trial Operations (Digital)

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:
We are currently searching for a Clinical Data Manager 2 to provide support the National Institutes of Health (NIH). The Clinical Data Analyst provides subject matter expertise for clinical data management on NIH clinical trials. The Clinical Data Analyst oversees data management of multiple complex studies, completes data entry and extraction, reviews data at critical time points, and serves as an internal data management expert.  This opportunity is full-time, and it is a hybrid / onsite role in Bethesda, MD.

• Manage NIH Clinical Data Management project timelines on multiple complex protocols or programs.
• Extract data from electronic medical records/source documentation and enter in clinical trial database following good data management practices.
• Provide guidance on core data management functions including eCRF design, edit check development, user acceptance testing, and reporting.
• Develop eCRF Completion Guidelines.  
• Develop protocol specific data management plans ensuring alignment with protocol and data quality standards.
• Responsible for the oversight of clinical data management study deliverables.
• Conduct data quality checks and data reviews.
• Collaborate with 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 protocol specific clinical research team meetings.
• Extract, grade, and manage adverse events based on the 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 study.
• Assist with the development, review, and implementation of clinical data management standard operating procedures (SOP) and processes.
• Evaluate and mitigate risks on protocols and across the program.
• Other duties as assigned.

What You Will Need:

• Bachelor’s Degree or additional FOUR (4) years of related experience in lieu of degree.
• At least four (4) years of data management experience.
• Experience with clinical/medical terminology required.
• 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).
• 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.
• Project management experience is required, specifically experience managing timelines.

What Would Be Nice To Have:

• Preferred areas of study are Life Science, Computer Science, or similar disciplines.
• Familiarity with computer platforms and databases such as clinical trial databases, clinical trial data management systems, or electronic data capture (EDC). Helpful to have experience with activities such as creating data management tracking systems, error-checking procedures, or back-up procedures to prevent loss of data.
• Knowledge of Federal information technology, Biotech or Pharmaceutical Industry, or equivalent comparable background.
• Good communication skills
• Proficient in MS Office, specifically Excel

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

• Care.com annual membership

• Employee Assistance Program

• Supplemental Benefits via Corestream (Critical Care, Hospital Ind