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Associate eTMF Manager

Covance 10/11/2018 7:42:56 PM
JOB ID: 24275 Category: Clinical Trial Management
King of Prussia, Pennsylvania

   

 

Job Overview

This position will be office based in the King of Prussia, PA office.

This position is responsible for supporting the Director of the Records Management function within processes Business Process & Solutions, implementing and maintaining Records Management systems and processes in CDCS to ensure compliance:

* Consolidation of various records management vendors for cost effectiveness.
* Implementing a streamlined, global process.
* Ensuring compliance in how CDS stores, retrieves, refiles records.
* Performing yearly testing of the process to ensure success during both audits and inspections.
* Leading the decisions for accurate destruction of global records based on corporate retention guidelines.
* Oversee and supervise the strategy execution for the records management components of the electronic trial master file system (eTMF) and the CDS records management needs.
* Support the Director of Business Process & Solutions by performing delegated management tasks.
* Create Standard Operating Procedures (SOPs) and Work Instructions for job functions within Records Managements, discovering and documenting process improvements.
* Conduct initial contract negotiations with document archival vendors.
* Plan for ongoing storage needs of paper documents.
* Participate in Covance project teams and client meetings, as appropriate.
* Ensure compliance of deliverables to applicable regulations, guidance requirements and client requests.
* Coordinate and support the preparation and maintenance of project plans for Records Management projects and for subsequent adherence to the plans.
* Present aspects of Records Management to auditors during client and/or regulatory inspections.
* Any other duties as requested by management.

Education/Qualifications

Recommended:

* 2 year college degree from an accredited institution or equivalent years of Experience in records management function or life sciences.

Preferred:

* 4 year University/college degree form an accredited institution or equivalent years of Experience .

Experience

Minimum Required:

* Project management Experience .
* Experience of Record management, retention, requirements and systems utlized in records management for the pharmaceutical industry.

Preferred:

* 2 years' Experience records management function in the pharmaceutical industry.


Position Type: Full-Time

Location: King of Prussia, PA - Pennsylvania



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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).