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Lead Clinical Data Manager, Labs

Covance 10/1/2018 5:41:48 PM
JOB ID: 24274 Category: Clinical Data Management
Austin, Texas

   

 

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

1. Bachelor's degree in Medical or Life Science, Mathematics or RN
2. Six plus years Experience in CDM or Biostatistics in a CRO or the pharmaceutical industry
3. Experience in WFH setting and has shown independence and success in this setting
4. Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position
5. Biomarker Experience or willingness to learn is a plus but not a requirement

Education/Qualifications

1. Bachelor's degree in Medical or Life Science, Mathematics or RN

Experience

1. Six plus years Experience in CDM or Biostatistics in a CRO or the pharmaceutical industry
2. Experience in WFH setting and has shown independence and success in this setting
3. Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position
4. Biomarker Experience or willingness to learn is a plus but not a requirement


Position Type: Full-Time

Location: Austin, TX - Texas



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).