Job Description

In this role, you will be responsible for the creation and review of Data Transfer Agreements, the correlation and/or entry of preclinical and clinical data into excel and the conduct of tasks performed within compliance of the study protocol. Responsible for acquisition of study data from data sources and processing of data through specialized software. Generate and complete, SEND datasets for regulatory submission and implementing CDISC standards. Responsible for the preparation of the required nSDRG (Nonclinical Study Data Reviewer’s Guide) document and Data Define file. Proficient use of SEND validation tools and the ability to resolve or explain findings. Perform quality control review on the complete SEND datasets, with great attention to detail to ensure data accuracy and alignment with the study report.

We are looking for candidates who have a passion for learning and teaching, with the patience and listening skills to appeal to the perspectives and interests of others. If you are able to balance confidence with humility while driving quality and efficient projects, then you’ll be right at home here at BioAgilytix.

Essential Responsibilities

• Understand industry documents such as the study plans/protocols, data transfer agreements, drafts and final reports.
• Export and/or manually enter data entries for completeness.
• Record, track and ensure the resolution of data queries/data reconciliation.
• Review data entry procedures for potential errors and/or logic discrepancies.
• Ensure work is compliant with applicable guidelines and regulations.
• Create specific SEND domains and/or Define file in adherence with CDISC standards and in adherence with requirements.
• Understand CDISC controlled terminology, if applicable.
• Ability to run SEND validation tools and use independent judgement to provide solutions to discrepancies and findings between SEND datasets and study documentation.
• Provide nSDRG content on specific SEND domains.
• Maintaining an understanding of evolving CDISC SEND standards and other regulatory standards/guidance.
• Communicate effectively project status/updates on any issues that may potentially impact quality and/or on time delivery.
• Perform general administrative tasks when required as assigned by management.

Minimum Preferred Qualifications - Education

• Associate’s or Bachelor’s degree and related work experience

Minimum Preferred Qualifications - Experience

• Two years' related experience in a scientific environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Minimum Preferred Qualifications - Skills

• Excellent communication and interpersonal skills,
• Ability to work in fast-paced environment where multiple concurrent projects must be completed in a timely manner.
• Requires analytical thinking skills and an understanding of scientific data.
• Previous experience with data transfers and data reconciliation.
• Basic knowledge with Microsoft Office suite.
• Proficient in the use of MS Excel required.
• Ability to learn LIMS and other software systems.
• Great attention to detail required.

Supervisory Responsibility

• This position has no supervisory responsibility

Supervision Received

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment

• Primarily office environment ( i.e., blend of office and work-from-home)
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Exposure to biological fluids with potential exposure to infectious organisms
• Potential exposure to skin and lung irritants, toxic materials, and hazardous waste
• Exposure to fluctuating temperatures on rare occasions

Physical Demands

• Ability to work in an upright and/or stationary position for up to 8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
• Occasional mobility needed
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moving) objects, including laptop computer, with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance

Position Type and Expected Hours of Work

• This is a full-time position
• Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required