QC & Data Management Lead

Flourish Research; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with employer match

Tuition reimbursement

Parental leave

Employee referral program

Life insurance

Disability insurance

Generous PTO

Job summary

Flourish Research is seeking a QC & Data Management Lead for a remote, United States-based position. The role requires overseeing data quality, guiding a team of QC/Data Management Specialists, and ensuring adherence to SOPs, GCP, FDA guidelines, and sponsor protocols.

You will collaborate with CRCs and CRAs, enter data into eCRF/CRF systems, and drive timely resolution of data queries while supporting monitoring visits and process improvements.

Qualifications

• Bachelor's degree or commensurate experience in life sciences or health care.
• Minimum 2 years in QC/Data Management or related clinical research role; leadership experience preferred.

Responsibilities

• Lead QC & Data Management team to ensure accuracy and timeliness of data entry.
• Review study charts according to SOPs, GCP, FDA guidelines and sponsor protocols.
• Enter data into eCRF/CRF systems per guidelines and timelines.
• Identify and report data discrepancies to CRCs promptly.
• Oversee sponsor monitor visits and assist in resolving data queries.
• Conduct regular team meetings and provide 1:1 coaching to staff.

Skills

GCP knowledge

MS Office

Data management

Team leadership

Quality assurance

Education

Bachelor's degree

Clinical research certification

Tools

eCRF/CRF systems

SOPs

Job description

About Us:

Flourish Research is where clinical trials thrive.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. WESEEYOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

About the Job:

We are actively hiring a QC & Data Management Lead. This is a remote position.
Shift: Monday-Friday (40 hours per week)
Location: Remote- United States

PURPOSE: Assure quality research data is collected by adhering to Flourish Standard Operating Procedures (SOPs), GCP, FDA, and protocol guidelines for all subject data that is submitted into the QC data entry department. Work closely with clinical research coordinators (CRCs) and ensure that the QC data entry department is utilizing the Punctual Accurate Complete True (P.A.C.T.) System. Assist clinical research associates (CRAs) during internal monitoring visits.

ESSENTIAL JOB FUNCTIONS:

1. Conduct a thorough and precise review of all study charts utilizing Flourish SOPs and sponsor-provided protocols.

1. Accurately enter data into an eCRF/CRF system according to the sponsor provided eCRF/CRF guidelines in a timely manner.

1. Identify and report any missing data points or inconsistencies to the CRC in a timely manner to ensure all data is clean and accurate.

1. Source document creation/approval.

1. Report any discrepancies between the source and CRF/eCRF immediately to the primary CRC and/or Team Lead.

1. Notify Operations Leadership, Team Lead, and CRC of any major discrepancies and deviations in a timely manner.

1. Resolve open queries thoroughly, accurately and in a timely manner.

1. Assist in sponsor monitor visits to resolve queries in a timely manner.

1. Perform all assigned duties in a timely- and cost-effective manner.

1. Actively learn and seek opportunities to expand expertise as a Lead, QC & Data Management.

1. Oversee quality/quantity of QC & Data Management Specialists to ensure that all assigned tasks are completed accurately and in a timely manner.

1. Perform employee 1:1s.

1. Conduct regular team meetings.

1. Train new employees regarding QC/DE processes.

1. Attend pre-study visits (PSVs) and site initiation visits (SIVs).

1. Attend manager meetings.

1. Efficiently and effectively oversee the QC Data Entry department.

1. Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.

1. Additional duties as assigned by management.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

1. Work is normally performed in a typical interior/office work environment.

1. Local travel is required.

1. Monitor/Sponsor customer service.

1. Daily computer use.

1. Ability to sit and/or stand for extended periods of time as work is performed on computer.

1. Occasional evening and weekend work schedules.

1. Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.

1. Ability to drive and daily availability of an automobile.

MINIMUM REQUIREMENTS:

Education: Bachelor's degree or commensurate experience.

Experience: Minimum of 2 years in the department plus 2 years in related role within the clinical research industry. Must have industry certification, as applicable.

Knowledge and Skills:

1. Consistently demonstrates core values & high proficiency in skills set.

1. Must have the ability to understand medical terminology and research concepts.

1. Must have the ability to identify appropriate subject care, relate in a professional and knowledgeable manner to physicians, pharmaceutical sponsors/CROs.

1. Must have a basic knowledge of Good Clinical Practice (GCP), computer, internet, and Microsoft Office applications.

1. Manage multiple tasks, ability to prioritize, meet deadlines, work independently, exercise initiative, demonstrate sound judgement, and consistently demonstrate effective oral and written communication.

1. Develops and implements key initiatives in the department.

1. Identifies and implements process improvements for increased efficiency.

1. Builds and fosters relationships across teams.

1. Consistently accomplishes 80% of individual goals each quarter.

1. Serves as preceptor, mentor, and subject matter expert in the department.

1. Demonstrates strong critical thinking and decision-making skills resulting in sound judgment.

1. Flexible and able to multi-task and prioritize competing demands.

1. Ability to think independently and influence when appropriate.

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Researchcomplies withthe lawregardingreasonable accommodation for handicapped and disabled employees.