Data Manager(Inhouse)_Hybrid@Ontario,Canada

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Data Manager on a permanent basis. This is a hybrid role at Ontario, Canada.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

The Data manager will be responsible for leading data management (DM) activities for clinical trials including database set up, study conduct and close-out. The Data manager will work collaboratively with a cross functional team to maintain project timelines and to deliver high quality DM deliverables. Key responsibilities may include, but are not limited to:

• Lead Data management activities and ensure study deliverables meet timelines and quality standards.

• Review of Clinical research documents (e.g. protocols, Case Report Forms).

• Create and review electronic Case Report Form (eCRF) specifications.

• Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan. Develop edit rules/checks, query logic and query messages.

• Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.

• Create and provide training to the clinical team and sites.

• Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.

• Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.

• Coordinate the archiving of study databases and related documents

• Create Data Transfer Specifications and perform external vendor reconciliation.

• Perform SAE reconciliation.

• Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical