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Clin Data Mgr I

Covance 10/9/2018 12:24:04 PM
JOB ID: 23790 Category: Clinical Data Management
Maidenhead, United Kingdom

   

 

Job Overview

Covance is seeking a Clinical Data Manager to work within their Late Phase Data Management Department. You will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.

This role is permanent full time, office or homebased in the UK, Germany, Italy, Spain or Portugal.

Responsibilities/Duties:

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

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 qualifications.
* Broad knowledge of drug development process.
* 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 ICH 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 areas.
* Demonstrated skill for technical management of staff exceeding 5 employees.
* Financial management of gross revenues in excess of $250K per year.
* 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 operations.
* Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.


Position Type: Full-Time

Location: Maidenhead, UK - United Kingdom



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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).