Clinical Data Manager

2 weeks ago

Guelph, Canada Nutrasource Full time

Job description

**Position Overview**

**Clinical Data Manager**

Provide clinical data management support to CRO Operations group

Create and review electronic case report forms (eCRF) per study specific protocols

Develop, review, and maintain clinical databases

Manages secure database user access

Develop, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing)

Develop study specific Data Entry Instructions and provide EDC training and support to clinical coordinators, monitors, biostatistician or study participants as required

Develop data transfer agreements and specifications with various vendors

Reconcile electronic data transfers from vendors

Write, review and maintain eCRF completion guidelines, Data Management Plans (DMPs), and other clinical data management related documentation which outline and record data management activities

Clean data for study close out and perform all database lock procedures

Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the project team

Participate in conference calls and/or meetings with vendors, clinical sites, or sponsors as required

Use standard conventions, tools, references and process in support of the coding of medical terms

Ensures all clinical data management procedures are executed with a high attention to detail, accuracy and timelines

Maintains an attitude and philosophy consistent with the Company's standards

**Primary Responsibilities**

Responsible for creation, testing, maintenance and closure of clinical trial databases.

Other duties as required & as training and experience allow

Maintains an attitude and philosophy consistent with the Company's standards

**Core Competencies**:
Experience with clinical data management software

High attention to detail Excellent organizational skills

Proficiency with the use of computers and MS Office

Ability to work independently with efficiency and accuracy

Excellent interpersonal and public relation skills with ability to work well in a team

Knowledge of current GCPs

Fluent in English with strong verbal and written communication skills

Flexibility and agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues

and clients.

**Qualifications**

Bachelor’s degree in a scientific discipline or equivalent qualification and experience

Minimum of 2 years of clinical data management experience in the pharmaceutical industry or in a CRO

environment.

Knowledge of MedDRA and WHO Drug dictionaries is an asset

MedDRA coding training certificate is an asset

Schedule:

- 8 hour shift

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