Skills

Communication Test Prioritization Problem-solving Research Training Effective Communication Programming Databases Organization

Job Specifications

About SCiAN Services Inc.:

SCiAN Services Inc. is a contract research organization (CRO) providing clinical data management, biostatistics, medical writing, SAE management and custom database solutions to the pharmaceutical, biotechnology, and medical device industries.

SCiAN has its headquarters in Toronto, Ontario Canada. We are known in the industry for our client-oriented approach, high quality standards, response to time-sensitive deliverables and proactive/innovative problem-solving skills.

SCiAN Services Inc. maintains the highest standards for value, quality, return on investment and support in all the services we provide:

We invest in training our personnel and applying leading-edge technologies to the services we provide.
We provide our clients with the knowledge and experience to ensure the success of every study and customize our approach to meet the individual needs of each client.

Title: Clinical Data Associate II

Job Type: Hybrid (in office 2 days per week)

Reporting to: Manager / Vice President, Biostatistics & CDM

Job Summary

The Clinical Data Associate reviews and processes clinical trial data to ensure the accuracy and consistency of clinical databases.

Key Responsibilities

SS Reviews and adheres to the requirements of study-specific Clinical Data Management Plans

SS Assists and contributes to the compilation of the Clinical Data Management Plan documentation

SS Design and develop study databases as per CRF template and Clinical Data Management Plan

SS Create and implement custom data validation rules and checks as per Clinical Data Management Plan and Study-specific protocol

SS Assists in clinical database user testing and documentation

SS Prepares test data for user testing of database screens and edit checks

SS Performs clinical study data review (non-medical reviews) as required by Clinical Data Validation Plans

SS Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team

SS Verifies database changes as requested by Project or Database Manager

SS Updates clinical database based on queries, site-generated DCFs and DMP (internal resolutions)

SS Prepares relevant subject data files for internal audits and quality control

SS Participates in study-specific data entry training

SS Performs clerical and administrative support tasks for the CDM and BST group

SS Assists Project Managers in quality control processes: document tracking, scanning and database audits

SS Other duties as assigned

Qualifications

SS BSc. in Life Sciences preferred, or Bachelor's degree with equivalent knowledge/experience

SS Minimum 1 - 2 years of experience in a clinical database system

SS Experience with databases (e.g. Lotus Notes) and EDC systems

SS Medical Terminology an asset

SS Some knowledge of computer programming languages (e.g. SAS)

SS Effective communication and interpersonal skills

SS Ability to work under moderate supervision

SS Flexibility in prioritization changes

Compensation: $60,000-$80,000 annually, for full time employment in our office.

Candidates must be legally authorized to work in Canada.

We appreciate the interest of all applicants; however, only those selected for an interview will be contacted.

We are an equal opportunity employer and provide accommodations upon request.

About the Company

SCiAN Services Inc., is a contract research organization (CRO) providing clinical data management, biostatistics, medical writing, SAE management and custom database solutions to the pharmaceutical, biotechnology, and medical device industries. SCiAN has its headquarters in Toronto, Ontario Canada. We are known in the industry for our client-oriented approach, high quality standards, response to time-sensitive deliverables and proactive/innovative problem-solving skills. SCiAN Services Inc. maintains the highest standards fo... Know more