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Clinical Data Manager

Summary:

CLINICAL DATA MANAGER

Responsible for conducting and overseeing Clinical Data Management (CDM) activities of assigned clinical studies, in accordance with agreed-upon timelines and in compliance with regulatory requirements and quality standards as per industry best practice.  Responsible for ensuring that all CDM activities for assigned studies conducted within or on behalf of WCCTG (whether internal or external)

are continuously aligned with corporate needs, and are performed according to corporate SOPs. Responsibilities include but are not limited to data review, eCRF development for assigned studies, data validation checks, etc. Responsible for ensuring data is of high integrity; Development/maintenance of the Data Management Plan (DMP), Data Validation Plan (DVP), and other data management documentation as required.

 

Duties and Responsibilities:

  • Act as a first point of contact for all data management deliverables for assigned studies
  • Perform study set up activities, as required
  • Review and provide input to all study specific documents
  • Provide input to the CRF layout as per protocol requirement
  • Provide input into Edit Specifications
  • Responsible for database review, testing and UAT of edit checks specifications for assigned studies
  • Coordinate development and validation of study database
  • Declare database go-live/ database lock
  • Responsible for monitoring study progress and timely locking of database
  • Accountable for all data management study deliverables from study initiation to database lock
  • Adhere to WCCTG and Sponsor SOPs/SWPs as required
  • Ensure audit readiness of data
  • Manage relationships with internal and external customers at both the operations level and with functional peers
  • Ensure data management milestones are met according to agreed upon timelines with high quality
  • Coordinate and work closely Project Manager to ensure that study deliverables are met as per the timelines and with high quality
  • Participate in Study Kick Off meetings and Study Team meetings for the assigned studies
  • Manage vendors as needed for assigned studies
  • Provide accurate reports on assigned projects
  • Effectively communicate relevant project information to management
  • Resolve and/or escalates issues in a timely fashion
  • Attend client meetings as needed
  • Other duties and responsibilities as defined by supervisor

 

Technical Requirements

  • Knowledge of the Microsoft Office Suite
  • A proficient user of Microsoft Office Applications including PowerPoint, Word, Excel
  • Must have an excellent understanding of the conduct of clinical trials and clinical trial related systems CFR 21 and ICH regulations

 

Behavioral Requirements:

  • Customer focus
  • Understanding the needs of the internal or external customer and keeping them in mind when taking actions or making decisions.
  • Team player – effective participant as a team member and team leader.
  • Can demonstrate significant positive participation on successful teams.
  • Practices professionalism and integrity in all actions.
  • Demonstrates cooperation, self-control, discretion and flexibility to get the work done.
  • Problem solving techniques
  • Able to adapt to a changing environment and demonstrates a “make it happen” attitude.
  • Exhibits professionalism in negotiating sensitive issues.
  • Interpersonal Interaction
  • Demonstrates excellent people skills and a positive attitude.
  • Excellent verbal and written communication skills
  • Effective verbal communication and presentation skills.
  • Ability to write clear, succinct and convincing memos, letters and articles using original or innovative techniques or style.
  • Strong organizational skills
  • Ability to prioritize and to manage multiple tasks
  • as necessary.
  • Attention to detail
  • Produces high-quality, accurate work with minimal
  • oversight.

Qualifications:

  • Education and experience will  include a minimum of a Bachelor’s Degree and a minimum
  • 4 years of related industry experience with a strong emphasis in Clinical Data Management

Travel:

  • Less than 20%

 

 

 

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