Clinical Data Manager

iuvo BioScience, llc.; United States; Remote; MXN 1,528,000 - 2,037,000; Full time

Job summary

iuvo Clinical is a full-service ophthalmology-focused CRO dedicated to improving patient outcomes by accelerating ophthalmic breakthroughs from concept to commercialization. The Data Manager will serve as the expert in clinical data management, collaborating with clinicians, clients, vendors, and study teams to build and maintain robust trial databases.

The role requires strong knowledge of ICH/GCP guidelines, FDA data handling regulations, and hands-on experience with EDC and CTMS systems.

Qualifications

• Bachelor’s degree in mathematics, statistics, computer science, life science or related discipline.
• Minimum 3 years of relevant work experience in data management.
• Knowledge of GCPs and Federal Regulations; GCP certification preferred.
• Experience with EDC systems and CTMS.

Responsibilities

• Interface with Project Manager(s) and statistician(s) to establish data management plans and requirements and database implementation schedules.
• Participate in system design, utilization, and maintenance to ensure FDA data management compliance.
• Collaborate with biostatisticians in creating analysis datasets.
• Perform database QA audits as needed.
• Provide recommendations to improve project efficiencies.
• Review protocols for CRF design and develop electronic CRFs.
• Complete study-specific database build activities in EDC with design specs and edit checks.
• May train site personnel in EDC/IWR systems and maintain training docs.
• Develop Data Management Plan (DMP) and ensure timely updates.

Skills

GCP & FDA regulations

EDC systems

SAS & SQL

Data analysis & listings

Microsoft Office

Communication skills

Education

Bachelor’s Degree in relevant discipline

Tools

CTMS

Crystal Reports

Microsoft SQL Reporting Services

SAS

SQL

Job description

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 clinical trial 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 Manager to join our team!

SUMMARY

The Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. The Data Manager effectively works with a variety of key stakeholders including clinicians, allied healthcare personnel, clients, vendors, and iuvo Clinical staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Interface with clinical Project Manager(s) and statistician(s) to establish project data management plans and requirements, and database implementation schedules as well as other key study documents.
• Participate in the department project clinical data system design, utilization, and maintenance to maintain conformance with FDA guidelines for clinical data management.
• Collaborate with biostatisticians in the creation of analysis datasets.
• Perform database quality assurance audits as needed
• Provide recommendations for improvement of project or divisional efficiencies based on work experience and observations.
• Participate in project review meetings as requested.
• Review protocols for CRF design and creation and develop electronic CRFs for use in clinical data management system.
• Complete study specific database build activities in EDC system by creating database design specifications and edit checks for database programming and complete UAT
• May complete database programming activities in EDC system or work with programmer to set up as per database design specifications
• May train clinical site personnel and project team in the use of study-specific EDC and IWR system(s); conducts timely training and maintains training documentation
• Develop the Data Management Plan (DMP) and associated attachments, initiates DMP review and update per the specified review cycle
• Conduct timely study team training on the DMP and applicable attachments; maintains study training logs for project team(s)
• Maintain up-to-date study data documentation
• May support database build activities in CTMS as needed
• Work with external vendors on study for external data needs, setting up data transfer specifications and complete external data reconciliation as needed
• Complete coding or work with coding team on set up and coordination of coding activities
• Manually review data listings and manage ongoing query resolution. Analyze, and interpret data to identify trends, patterns, and insights.
• Collaborate with teams to understand data requirements and provide data-driven recommendations.
• Serve as main point of contact for data management activities on assigned project, and provide updates to study team and sponsor on project calls as needed
• Develop and provide data management metrics to project team as needed
• Complete data cleaning and other activities required for database lock.
• Complete database lock activities as outlined in DMP
• Demonstrate knowledge of ICH/GCP guidelines as they relate to data management.
• Demonstrate knowledge of FDA regulations related to data handling and processing.
• Regularly provides or uploads data-related documents to the eTMF
• Ability to train junior data management team members

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.

EDUCATION and/or EXPERIENCE

• Bachelor’s Degree with a major/ focus in relevant discipline or equivalent - mathematics, statistics, computer science, life science or related discipline.
• Minimum of three years’ relevant work experience in data management.
• Strong working knowledge of GCPs and Federal Regulations.
• Current GCP certification required (or willing to obtain).

COMPUTER SKILLS

• Proficiency in data preparation, analysis tools and programming languages.
• Proficiency in one or more EDC systems.
• Proficiency with database design and systems, database technology and logical data analysis.
• Previous database programming experience preferred but not required.
• Experience working with CTMS and other clinical trial systems is preferred, as well as web-based software systems.
• Understanding of SAS, Microsoft SQL.
• Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable to position
• Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable.

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
• Sharing ideas in a constructive manner
• Listening to and objectively considering ideas and suggestions from others
• Keeping commitments
• 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

• Solid analytical and problem-solving skills; strong attention to detail and a commitment to data accuracy and integrity.
• Strong organizational and business skills, with particular strength in follow-through.
• Excellent interpersonal skills, including clear, succinct, and timely communication.
• Ability to work independently with ability to build relationships and foster trust.
• Leadership skills, and ability to work effectively within a team configuration.
• Ability to work on multiple projects and manage competing priorities.
• Familiarity with current data standards (e.g., XML/CDISC) and database administration.

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, talk and hear.

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

LOCATION Remote

TRAVEL As required, estimated as <5%.

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