Data Entry Manager

Data Entry Manager

Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panorama City, and Murrieta, and has recently expanded to Denver, Colorado.

Flourish Research is one of the industry's most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

We are actively hiring a Data Entry Manager for either our Century City, CA or Denver, CO sites.

LOCATION: Onsite, Denver, Colorado or Century City, California FLSA: Exempt HOURS: Monday to Friday, Day Shift, 40 hours per week COMPENSATION: $125,000 - $140,000 (based on experience)

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.