Data Manager(Inhouse)_Hybrid@Ontario,Canada

About this role

<p> </p> <p> </p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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 <strong>Data Manager</strong><strong> </strong>on a permanent basis. This is a hybrid role at Ontario, Canada. </span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!</span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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:</span></p> <ul> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Lead Data management activities and ensure study deliverables meet timelines and quality standards.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Review of Clinical research documents (e.g. protocols, Case Report Forms).</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Create and review electronic Case Report Form (eCRF) specifications.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan. </span><br><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Develop edit rules/checks, query logic and query messages.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Create and provide training to the clinical team and sites.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Coordinate the archiving of study databases and related documents</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Create Data Transfer Specifications and perform external vendor reconciliation.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform SAE reconciliation.</span></li> <li style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.</span></li> </ul> <p style="line-height: 1;"><strong><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Qualification</span></strong></p> <ul> <li><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.</span></li> <li><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Atleast 3 years data management and/or related work experience in a pharmaceutical industry.</span></li> <li><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.</span></li> <li><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.</span></li> <li><span…