Data Manager for Clinical Trials at PSI CRO — NeverHard
Data Manager for Clinical Trials at PSI CRO in Mississauga, Peel region. Skills: Clinical Data Management, Communication, Data Validation, Medical Coding, System Reconciliation. Apply on NeverHard.
Company
PSI CRO
Location
Mississauga, Peel region
Type
full_time
Required skills:
Clinical Data Management
Communication
Data Validation
Medical Coding
System Reconciliation
Training
database lock
eTMF Systems
technical query management
Job DescriptionJob DescriptionCompany Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,200 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Acts as a communication line for project teams regarding clinical data management
Maintains TMF/eTMF
Trains Assistant Data Manager
Is involved in clinical data management activities including, but not limited to:
Supporting development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
User acceptance testing
User access management
Data review
eCRF/External data reconciliation
Medical coding (for staff with medical/Life Science background)
Supporting SAE reconciliation
Query management
Local lab normal ranges entry and QC
Study Database Lock activities
Archival of CRFs QC
Data entry/QC
Project status reporting
Data listings/Patient profiles generation and delivery
Assisting with Database Lock tasks as needed for assigned projects
Qualifications
College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities
A minimum of one year of industry experience, preferably working with clinical or medical data