Clinical Data Manager_Canada(Permanent role)

at  ClinChoice

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.
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 data.

QUALIFICATION

• Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.
• Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
• Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.
• Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
• Perform duties in compliance with SOPs, GCP and ICH guidelines.
• Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
• Ability to lead a study or data management team independently.
• Proactively drive quality and efficiently to meet timelines and milestones to deliver high quality data management deliverables.
• Excellent verbal and written communication skills.
• Proficient in the use of Microsoft office(Outlook, word, excel, powerpoint, etc)

• 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 data