Clinical Study Data Reviewer

Title: Clinical Study Data Reviewer

Location: Rochester NY US

Job Description:

$60,000 ‒ $74,000 Annually

A Trusted CRO Partner for the Future of Eye Care

iuvo Clinical is a full-service ophthalmology-focused contract research organization (CRO) dedicated to improving patient’s quality of life with breakthrough eye care therapies. We combine decades of specialized experience with a high touch, high science approach, partnering with innovators to accelerate ophthalmic breakthroughs from concept to commercialization. Whether advancing a novel retinal therapy or supporting a complex ocular device trial, we provide the expertise, flexibility, and personal dedication to ensure your clinical trial’s success.

We offer a comprehensive benefits package and the opportunity to broaden your experience and grow your career!

We currently have an exciting opportunity for a Data Reviewer.

SUMMARY

The Data Reviewer is responsible for ensuring the accuracy, completeness and consistency of clinical trial data to meet all regulatory standards. The Data Reviewer, in coordination with data management teams, serves to identify and resolve data discrepancies in Electronic Data Capture (EDC) systems throughout the study lifecycle.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Maintain awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicate status updates to the Data Manager (DM) and/or Project Manager (PM) as necessary.
• Data Review & Quality Control: Review participant-level data, including vision testing results, to ensure adherence to study protocols.
• Query Management: Identify errors or implausible data and coordinate with study sites or IHCRA/Clinical Research Associates (CRAs) to resolve discrepancies.
• Review and adhere to the requirements of study-specific DMP for assigned project(s) and update as required.
• Compliance Monitoring: Ensure all data collection practices align with Good Clinical Practice (GCP), HIPAA regulations, and International Council for Harmonization (ICH) guidelines.
• In-Stream Trend Analysis: Conduct ongoing analysis and interpretation of data to identify data quality issues, safety signals, or protocol deviations early in the trial
• Support study-specific database builds, including development of edit checks and  perform User Acceptance Testing (UAT).
• Perform data listing reviews and based on the review, query or apply self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Management Plan (DMP) for the assigned projects. Resolve answered queries and re-queries where appropriate.
• Participate in completion of all activities necessary for the finalization and transfer the clinical database and related project documents to the sponsor.
• Maintain proficiency in DM systems and processes through regular training courses.
• Understand the coding process.
• Comprehend the purpose of interim, dry run, data cut.
• Participate in internal meetings.
• Attend in-process review meetings.
• Participate in internal/external audits as required.

QUALIFICATIONS & REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required and are not all-inclusive.

EDUCATION and/or EXPERIENCE

• Bachelor’s degree in a life science or related field preferred or related experience
• Requires 1–3 years of experience in clinical data review, monitoring, or data management.
• Knowledge of clinical data, and ICH/Good Clinical Practices.
• Work experience in clinical research, drug development, data management, or other healthcare environment preferred.
• Familiarity with medical terminology.
• Experience in ophthalmology therapeutic area preferred

      COMPUTER SKILLS

• Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills.
• Experience with DM practices and relational database management software systems

      COMMUNICATION SKILLS

This position requires a person who communicates effectively both verbally and in writing with clinicians, clients, vendors, and internal project team members through demonstration of:   

• Excellent presentation and interpersonal skills, including clear, succinct, and timely communication to different audiences  
• Sharing ideas in a constructive manner  
• Listening to and objectively considering ideas and suggestions from others  
• Keeping others informed of work progress, timetables and issues  
• Read and comprehend work instructions/SOPs and protocols and write clear, concise communications and documentation  

      OTHER SKILLS and ABILITIES

• Good organizational, planning, and time management skills
• Ability to multitask under tight deadlines while providing attention to detail.
• Ability to be flexible and adapt to change.
• Ability to work independently as well as be part of a multi-disciplinary team.
• Solid problem-solving skills

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 While performing the duties of this job, the employee is regularly required to sit or stand at a desk, type, talk, see and hear.

 WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Office setting / remote home office. iuvo Clinical fosters a video-first environment; employees are expected to have their cameras on for all internal and external meetings, check-ins, and collaborative sessions.

 Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

LOCATION Remote

 TRAVEL 10%.

 DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

 iuvo Clinical is an Equal Opportunity Employer