Data Management Specialist manages data entry from the source documents into CRF’s. Specialists collaborate with the clinical study team to take a pro-active approach to identify issues regarding data collection. Data Management Specialist completes data forms and queries in the specified timelines. 

To consistently embody AMR Clinical’s Core Values:

• United We Achieve
• Celebrate Diverse Perspectives
• Do the Right Thing
• Adapt and Persevere

The Data Management Specialist reports to the Clinical Data Manager.

Classification: Non-Exempt

Shift: Monday-Friday normal office hours 

Primary Responsibilities:

• Ensure Compliance with Regulatory & Sponsor Requirements – Adhere to ICH-GCP, FDA, and sponsor-specific requirements for data management and documentation.
• Monitor Data Trends & Report Deviations – Identify patterns in data entry errors and escalate potential protocol deviations or systemic issues to the appropriate team members.
• Collaborate with Study Teams for Query Resolution – Work proactively with CRC, QA, and monitors to address open queries and improve data accuracy.
• Assist in Preparing Sites for Audits & Monitoring Visits – Ensure data reconciliation, regulatory compliance, and complete documentation before external reviews.
• Contribute to Study Start-Up & Closeout Activities – Assist in database lock procedures, final query resolution, and archiving of study records.
• Ensure timely and accurate CRF completion for each study subject. 
• Review data entered to ensure accuracy
• Complete CRF data entry in a timely basis according to specified timeline per the protocol. 
• Review source documents for accuracy
• Maintain source document and logs throughout the study
• Upload documents into eSource
• Confirm proper randomization procedures are followed. 
• Schedule and assist with on-site monitor visits.
• Submit internal queries to clinical staff as needed. 
• Attend site initiation visits for current assigned protocols. 
• Assist with requests from monitors and auditors for completed CRF’s and patient records. 
• Develop rapport and maintain professional communication with team members, subjects, sponsors, monitors, etc. 
• Identify trends and systematic issues, escalate to CRC and QA. 
• Complete protocol specific, eSource training as applicable
• Work with coordinator to complete SAE information if CRF is used in reporting.
• At study closure, ensure all CRF’s are completed, and all data entered as appropriate. 
• Position may require occasional weekend and/or overtime hours. 
• Other duties as assigned

Desired Skills and Qualifications:

• Proficiency in managing confidential and sensitive information with discretion.
• Strong analytical and problem-solving skills with attention to detail.
• Experience with data entry programs preferred.
• Ability to learn and be proficient in various web-based data entry programs. 
• Advance knowledge in operating office equipment and software programs
• Excellent verbal and written communication skills. 
• Strong interpersonal skills
• Strong multi-tasking skills and organizational skills
• Attention to detail
• Motivated, self starter, and exercises initiative. 
• Excellent follow-up skills.
• Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.

AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.