Successful candidate will provide support and expertise for the Global Medicines Development Affairs (GMDA) archive. He/She will hold a primary responsibility for management of the physical archive and for document processing of a variety of documents in multiple formats. He/She will also be accountable for specific pieces of moderately complex ongoing archive projects. In addition he/she will be responsible for fielding and processing requests from internal and external users.
- Manage the day to day activities of the physical archive
- Work with existing electronic systems, to archive and search clinical records appropriately to facilitate prompt retrieval
- Manage CRO/vendor record migrations
- Work with TMF Compliance and Oversight team to ensure appropriate archiving processes are in place for eTMF
- Carry out complex searches across various internal and external systems to ensure retrieval of complete and accurate information as it relates to inspection readiness
- Collaborate with GMDA functions to maintain a compliant and inspection ready Clinical archive.
- Coordinate off site archival activities, including interaction with off-site archive facilities for data storage and retrieval
- Support compliance activities for internal and external inspections and audits
- Lead review of procedures to identify gaps and revise accordingly
- Analyze new regulations and guidelines and make process improvement recommendations
- Represent TMF Compliance and Oversight on assigned project sub-teams and/or task forces with a focus on continuous improvement
- May serve as Primary GCP Archivist
- May represent TMF Compliance and Oversight group during regulatory inspections related to Clinical archive activities
- Perform other duties as assigned
Managerial and Communicative Skills:
- Exhibits leadership skills
- May supervise, mentor and train colleagues
- Demonstrate sound knowledge and understanding of applicable GCP regulations and industry best practices
- Possesses detailed knowledge of records management and archiving principals, procedures, and common best practices
- Demonstrated proficiency using Microsoft Office applications required (including Excel, Powerpoint and SharePoint).
- Display project management skills to independently manage TMF projects
- Independently solve problems of moderate complexity with limited supervision
- Identify areas of risk and escalate as appropriate
- Skilled with managing multiple assignments simultaneously.
- Strong interpersonal and communication skills. Support preparation for presenting to, educating and training of teams and other stakeholders. May lead or present portions of material at team meetings.
B.S (or equivalent experience) and 2-4 years of relevant work experience or
M.S. (or equivalent experience) and 1-3 years of relevant work experience* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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