Lead Clinical Lab Data Manager
Covance
Toronto, Ontario
9d ago

Job Overview

Lead CDM (Specializing in Lab Data)

Permanent, salaried

Location : Remote (US or Canada)

JOB SUMMARY

Supervise all project data processing tasks. Work to departmental SOPs, guidelines and global standards to ensure data integrity.

JOB RESPONSIBILITIES

Thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.

Monitor tasks vs. contractual obligations for CDM and report any out of scope items to the Project Data Manager. Provide oversight to external suppliers such as EDC vendors.

Coordinate, create and maintain the Data Management Plan, Data Transfer Specifications, Data Validation Specifications, eCRF Completion Guidelines and training materials.

Work with KickStart and Sponsor on start-up activities. Sign off on documentation as required by SOPs and WPGs. Attend & present CDM materials at Investigator & CRA meetings.

Attend and lead internal and external project meetings providing input from a lab CDM perspective. Ensure assigned actions are completed within the required timeframe.

Assist with tracking of project status, task completion, and staff productivity. Determine status of incoming data, site responsiveness, need for escalation for backlog to various functions within Chiltern or sponsor.

Report and discuss findings with Project Data Manager and directly with other study team members.

Review and approve post production change control study documentation.

Ensure filing of study specific documentation as required by SOPs and WPGs and study needs. Maintain all data management study documents in the designated TrialShare area and PMF as required.

Provide reports to Sponsor and internal team as dictated by project need.

Be a resource to CDM team for questions and guidance as related to lab clinical data.

Contribute to the development and / or revision of Clinical Data Management SOPs and related documentation.

Gather and consolidate feedback, metrics and status reports from CDM Team Leads to assess CDA performance and quality of deliverables.

Escalate any performance and quality issues to PDM.

Ensure company and departmental SOPs and standards are adhered to.

Provide feedback for performance evaluation and competency of Data Managers and assist with skill / career development for direct reports.

Be responsible for effective management of projects / sponsor groups, and assigned Data Managers (max. 4).

Present CDM function at conferences and external non-study meetings.

KEY SKILLS & BEHAVIORS

Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills

Keeps an internal and external client informed of project and / or technical issues by pro-actively communicating across teams / functions

Manage data transfer specifications, data mapping specifications to get the raw data into sponsor standard formats, lab data review and cleaning, lab data validation specifications

  • Lab experience; lab data managers liaise directly with many small laboratories and need to be able to effectively communicate with them.
  • Knowledge of lab testing would be especially helpful

    Manage and directly supervise assigned clinical data management team

    Communicates effectively through both written and verbal methods

    Anticipates changing priorities and demands and addresses them proactively

    Manages time effectively in order to produce a quality deliverable in expected timeframe

    Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills

    TRAINING AND EXPERIENCE

    Bachelor’s degree in Medical or Life Science, Mathematics or RN

    Six plus years experience in CDM or Biostatistics in a CRO or the pharmaceutical industry

    Experience in WFH setting and has shown independence and success in this setting

    Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position

    Biomarker experience or willingness to learn is a plus but not a requirement

    Education / Qualifications

    TRAINING AND EXPERIENCE

    Bachelor’s degree in Medical or Life Science, Mathematics or RN

    Six plus years experience in CDM or Biostatistics in a CRO or the pharmaceutical industry

    Experience in WFH setting and has shown independence and success in this setting

    Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position

    Biomarker experience or willingness to learn is a plus but not a requirement

    TRAINING AND EXPERIENCE

    Bachelor’s degree in Medical or Life Science, Mathematics or RN

    Six plus years experience in CDM or Biostatistics in a CRO or the pharmaceutical industry

    Experience in WFH setting and has shown independence and success in this setting

    Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position

    Biomarker experience or willingness to learn is a plus but not a requirement

    Position Type Full-Time

    Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).

    Your confidentiality and privacy are important to us.

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