F

Flourish Research

Clinical trial optimization and operations efficiency

Data Entry Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time$125k - $140k

About the Job

Requirements

  • A bachelor's degree in Health Information Management, Medical Assisting, or a related field, or equivalent experience; commensurate experience may be considered in lieu of a degree.
  • At least 5 years of relevant experience, including at least 2 years of supervisory experience within clinical, medical, or healthcare data management.
  • 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 Microsoft Office and internet-based applications.
  • Strong written and verbal communication skills, including the ability to communicate professionally and knowledgeably with stakeholders such as physicians and pharmaceutical sponsors or contract research organizations.
  • Ability to read, understand, and interpret patient medical records in 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 independently and in a team environment.
  • Initiative, sound judgment, and decision-making skills.
  • Ability to lead and drive implementation of key team initiatives.
  • Ability to collaborate and build relationships across teams.
  • Attention to detail and organizational skills.
  • Critical thinking and problem-solving skills.
  • Ability to provide effective process and technical leadership.
  • Ability to properly lift 25 pounds.
  • Occasional night and weekend work schedules may be required.

Responsibilities

  • Oversee and lead team members entering clinical trial data into case report forms (CRFs) or clinical data management systems (CDMS), ensuring alignment with source documents.
  • Serve as an operational and technical leader and subject matter expert in the department.
  • Hold Data Entry staff accountable for completing assigned tasks accurately and on time.
  • Serve as an escalation resource to troubleshoot complex process and technical challenges for the data entry team.
  • Ensure data entry processes and execution comply with Good Clinical Practice (GCP) guidelines and clinical standards, including a quality-control step.
  • Manage and resolve escalated issues involving missing data points or inconsistencies to ensure data is clean and accurate.
  • Manage and resolve escalated discrepancies between source records and CRF/eCRF with clinical research coordinators (CRCs) and/or the Clinical Team Manager.
  • Consult with Senior Leadership, the Clinical Team Manager, and CRCs about major discrepancies and deviations in a timely manner.
  • Ensure the team resolves open queries thoroughly, accurately, and promptly.
  • Attend and participate in pre-study visits (PSVs) and site initiation visits (SIVs).
  • Represent management during sponsor monitor visits to resolve queries and escalated issues promptly.
  • Supervise, schedule, and coordinate assigned staff.
  • Conduct performance evaluations and provide coaching, mentoring, and performance management.
  • Facilitate staff onboarding, orientation, and ongoing training.
  • Lead regular data entry team meetings.
  • Train employees on data entry processes and procedures.
  • Identify, develop, and implement process improvements.
  • Maintain confidentiality and integrity of study data and participant and patient information.
  • Address team resourcing needs.
  • Prepare and present reports on team performance, staffing, and incidents to senior leadership.
  • Participate in cross-functional meetings and represent data entry staff interests.
  • Lead team policy development and implementation.
  • Perform assigned duties in a timely and cost-effective manner.
  • Occasional local travel may be required.

About the Company

Flourish Research

Clinical trial optimization and operations efficiency

Flourish Research helps healthcare and pharmaceutical clients run clinical trials more efficiently. It offers tailored optimization services that improve trial operations, aiming to reduce time and costs to bring new treatments to market. The company leverages decades of experience to provide quality-driven solutions, focusing on expanding capabilities, developing healthy teams, and implementing processes that enhance speed and quality across trial activities. Flourish Research differentiates itself by its client-specific approaches and strong emphasis on quality, team development, and operational excellence to deliver reliable trial outcomes.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Apex, NC
Founded
2021

Recently Posted Jobs

Explore more opportunities at Flourish Research

See more jobs