Hybrid Data Manager – Permanent

Posted yesterday

Apply now

About the role

  • Data Manager leading data management activities for clinical trials at ClinChoice. Ensuring deliverables meet timelines and quality while collaborating with cross-functional teams.

Responsibilities

  • 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.

Requirements

  • 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)

Job title

Data Manager – Permanent

Job type

Experience level

Mid levelSenior

Salary

CA$65,000 - CA$80,000 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job