Data Entry Manager

Purpose

Manages the function of and team performing data entry, updating, and maintenance of clinical and patient data into sponsor Electronic Data Capture (EDC) platforms and clinical data management systems (CDMS). Provides operational and technical guidance to ensure data is entered accurately, timely, and in compliance with policy, procedural, privacy, and regulatory requirements. Works closely with cross functional managers, clinical research coordinators (CRCs), and members of the data entry team to ensure timely data entry and query resolution per timelines outlined in the study data entry plan and CTA. Serves as a data entry management representative for Sponsors and CRAs to assist in meeting timelines related to interim analysis and data cuts.

Essential Job Functions

• Provides oversight and leadership to team members in the entry of clinical trial data into case report forms (CRFs) or clinical data management systems (CDMS), ensuring alignment with source documents.
• Serves as an operational and technical leader as well as subject matter expert in the department.
• Drives accountability for Data Entry staff to ensure that all assigned tasks are completed accurately and in a timely manner.
• Serves as an escalation resource to troubleshoot complex process and technical challenges for data entry team.
• Ensures data entry processes and execution are in compliance with Good Clinical Practice (GCP) guidelines, clinical standards, and includes a quality control step.
• Manages and resolves escalated issues with missing data points or inconsistencies in a timely manner to ensure all data is clean and accurate.
• Manages and resolves escalated discrepancies between the source and CRF/eCRF with CRCs and/or Clinical Team Manager.
• Consults with Senior Leadership, Clinical Team Manager, and CRCs on major discrepancies and deviations in a timely manner.
• Ensures team resolves open queries thoroughly, accurately and in a timely manner.
• Attends and engages in pre-study visits (PSVs) and site initiation visits (SIVs).
• Acts as a management representative during sponsor monitor visits to resolve queries and escalated issues in a timely manner.
• Supervises, schedules, and coordinates assigned staff.
• Conducts performance evaluations and provides coaching, mentoring, and performance management.
• Facilitates onboarding, orientation, and ongoing training for staff.
• Leads regular data entry team meetings.
• Trains employees regarding data entry processes and procedures.
• Drives identification, development, and implementation of process improvements.
• Represents the Company in a professional and courteous manner when interacting with all staff and sponsors.
• Maintains confidentiality and integrity of study data and all participant/patient information.
• Addresses team resourcing needs.
• Prepares and presents reports on team performance, staffing, and incidents to senior leadership.
• Participates in cross-functional meetings and represents data entry staff interests.
• Leads team policy development and implementation.
• Performs all assigned duties in a timely- and cost-effective manner.
• Additional duties as assigned by management.

Physical Requirements and/or Environmental Factors

• Work is normally performed in a typical interior/office work environment and/or remote office setting.
• Occasional local travel may be required.
• Daily computer use.
• Occasional night and weekend work schedules.
• Ability to properly lift 25 pounds.

Minimum Requirements

• Education: Bachelor’s degree in Health Information Management, Medical Assisting, or related field, or equivalent experience. Commensurate experience in lieu of degree may be considered.
• Experience: Minimum 5+ years of relevant experience, including 2+ years’ supervisory experience within clinical, medical, or healthcare data management.

Knowledge and Skills

• Strong leadership and process improvement skills.
• High proficiency with Electronic Medical Records (EMR), Electronic Data Capture (EDC) platforms and clinical data management systems (CDMS).
• Strong working knowledge of medical terminology, clinical documentation standards, and research concepts.
• Excellent working knowledge of Good Clinical Practice (GCP).
• Strong knowledge of HIPAA regulations and patient data confidentiality requirements.
• Proficiency in MS Office and internet-based applications.
• Strong written and verbal communication skills.
• Ability to communicate in a professional and knowledgeable manner with various stakeholders, including physicians and pharmaceutical sponsors/CROs.
• Ability to read, understand, and interpret patient medical records in both paper and electronic formats.
• Ability to ensure and audit data with a high degree of accuracy.
• Ability to handle multiple tasks, prioritize competing demands, meet deadlines, and work both independently and in team environment.
• Demonstrates initiative, strong judgement, and decision-making skills.
• Ability to lead and drive implementation of key initiatives for the team.
• Ability to collaborate as well as build and foster relationships across teams.
• Excellent attention to detail and organizational skills.
• Strong critical thinking and problem-solving skills.
• Ability to provide effective process and technical leadership.
• Consistently demonstrates core values and high proficiency in skills set.