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 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)

The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following):

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

#LI-TT1 #LI-Remote #Senior #FTE

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Clinical Data Manager(Permanent role)_Hybrid/Ontario,Canada

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