Job Description

Overview

KGK Science is a world-leading Contract Research Organization specializing in the conduct of human research studies and regulatory services for the Natural Health Product industry. KGK is a dynamic, fast-paced and friendly work environment that will suit an energetic and strategic thinker with clear vision and solid communication skills. This is an opportunity for a highly motivated professional individual to join a respected company in an exciting and growing industry.

We are seeking a motivated and talented individual for our Data Management Team as a Data Management Specialist.

Required Experience:

At least 1 year of industry experience

Robust knowledge of ICH-GCP Guidelines, local regulatory requirements

Experience with database development and maintenance

Education

Minimum College diploma/Bachelor's degree in data-specific or life sciences discipline

Required Skills

Strong attention to detail in data entry, review, and validation Ability to prioritize and manage multiple tasks in a deadline-driven environment Strong organizational and time-management skills Clear verbal and written communication skills Ability to follow documented procedures (e.g., SOPs) consistently Strong analytical and problem-solving skills Ability to identify, document, and escalate data issues appropriately Comfortable working with study data and cross-functional teams

Technical skills (required):

Hands-on experience with Electronic Data Capture (EDC) systems Strong Microsoft Excel skills (filters, formulas, data checks) Experience supporting eCRF and ePRO testing and User Acceptance Testing (UAT)

Technical skills (asset):

SQL or database querying experience Microsoft Access Tableau or other data visualization tools

Roles and Responsibilities

Develops and reviews data management SOPs and updates as needed.

Develops the data management plan (DMP) and updates as required

Develops a data validation plan (DVP)

Ensures all team members follow DMP, DVP, and SOPs

Performs User Acceptance Testing (UAT) of the database forms

Design, develop, and test eCRF and ePRO (end-user forms)

Provides end-user material, including programming logic documentation, for submission to the regulatory affairs associate for ethics submissions

Performs quality control of eCRF and ePRO prior to launching the database and throughout the study

Support training and guidance of internal teams, clinic staff, and CRAs on the database and eCRF

Creates and manages users in the database

Manages data flow from multiple sites, when necessary

Performs data validation and collaborate with the clinic and CRA teams to resolve any issues

Performs medical coding

Locks the database and provides it to Biostatistician, research team, and client

Provides subject disposition information and database map of the study to Biostatistician, research team

Addresses data related queries in a timely manner

Archives clinical material and maintains archive databases

Attend meetings as needed

Performs ad-hoc duties as required

Language Skills

Fluent in written and spoken English

Job Types: Full-time, Permanent

Pay: $45,000.00-$55,000.00 per year

Benefits:

Dental care Extended health care Paid time off Vision care
Work Location: Hybrid remote in London, ON N6B 3L1