Data Management Specialist

Alliance For MultiSpecialty Research LLC • Knoxville, TN

4h

About The Position

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

Requirements

• 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.
• Fluent in English.

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

What This Job Offers

• Career Level: Entry Level
• Education Level: No Education Listed