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Clinical Data Manager I

Covance 10/2/2018 5:08:06 PM
JOB ID: 23794 Category: Clinical Data Management
Austin, Texas

   

 

Job Overview

Clinical Data Manager 1

Remote, Home-Based in the USA or Canada

The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.

Additional responsibilities include:

* Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate i n the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specificationsImonitoring conventions.+ Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppo1t, drug safety, etc.) to suppo1t the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
* Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
* Review data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion
* Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
* Advanced planning and risk management for projects (issue escalation, resource management).
* Assist with goal creation and performance review assessment for data review project staff.
* Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.+ Support achievement of project revenue and operating margin for data management activities to agreed target
* Identify areas for process and efficiency improvement and implement solutions on assigned projects.
* Maintain technical data management competencies via pa1ticipation in internal and external training seminars.
* Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
* Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as
* Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
* Perform other duties as assigned by management.
* Review literature and research technologies/procedures for improving global data management practices.

Education/Qualifications

* University/college degree (life science, pharmacy or related subject preferred), or certification
* in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
* Additional relevant work Experience will be considered in lieu of formal qualific
* Broad knowledge of drug development processes.
* Understanding of global clinical development budgets and relationship to productivity targets.
* Knowledge of effective clinical data management practices.
* Knowledge of time and cost estimate development and pricing strategies.
* Thorough knowledge of TCH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

Experience

* Minimum five (5) years relevant work Experience in data management with approximately one (1) year technical supervisory Experience to include data management, clinical operations, and knowledge of several therapeutic ar
* Demonstrated skill for technical management of staff exceeding 5 employees.
* Financial management of gross revenues in excess of $250K per
* Excellent oral and written communication and presentation skills.
* In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operation
* Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical I biotechnological
* Ability to lead by example teams on project strategies and achievement of depa11ment goals, objectives, and initiatives and to encourage team members to seek so
* Demonstrated managerial and interpersonal skill

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.


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).