Clinical Data Manager
6 months ago
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
Work Location: In person
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