Teva Pharmaceuticals Clinical Records & Information Management Associate in West Chester, United States
Clinical Records & Information Management Associate
Date: May 10, 2023
West Chester, United States, 00000
Company: Teva Pharmaceuticals
Job Id: 48180
Who we are?
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The main objective of the CRIM Associate is to support Global Clinical Operations (GCO) organization in the processing, review, QC, and archiving of the clinical operations portion of the Trial Master Files (TMF/TMFs) and all other CRIM associated activities and responsibilities.
This involves support to the GCO functions and CRIM in the tracking, planning, set-up, oversight, and data archival activities as well as ensuring quality records deliverables for TMFs & eSubmissions.
Responsible for the processing, QC and archive of GCO study related TMF documentation. Works to ensure a timely delivery and perform QC of TMF content (i.e. CRF pages and non-CRF data for e-submissions). Follows Teva safety, health, and environmental policies and procedures. Performs other GCO related tasks, projects and duties as required/assigned.
The CRIM Associate is also responsible to support GCO with preparing and participating in internal and external TMF oversight, leading efforts related to TMF Review (ongoing & end of study), and supportive actions in TMF audits.
In addition, the CRIM Associate will be responsible for using and maintaining automated archives and records management systems, including those used by the Records and Information Management (RIM) department to index, store and access records/information.
Essential Duties & Responsibilities:
Support Global Clinical Operation teams in TMF and eTMF processes, including the completion of TMF Review Plans, document management plans and sponsor study TMF review plans.
Perform TMF oversight activities –TMF reviews and QC
Management of external and internal TMF reviews- Inventory and QC of Clinical Documents ensuring GCO TMF files are structured according to Teva SOPs and completed as required.
Management of TMF processes and coordination of transfers of TMF from external parties; includes providing instructions for inventory, labelling and shipping as well as entry of records into the archival tracking system.
Participate in GSD inspection readiness efforts, including supporting pre, during and post inspection activities related to completeness and quality of the clinical portion of the TMF
Responsible for collation of TMF documentation required in preparation of, and for, internal and external audits
Perform operational activities related to records receipt, data-entry and indexing, onsite and offsite storage, reference, retrieval and disposal activities to support the overall CRIM organization.
Other tasks assigned by direct manager or as business needs require.
Your experience and qualifications
At least 3 years of experience in clinical records management department at CRO, Sponsor or other relevant vendors
Practical experience working with Trial Master File regulations and DIA reference model.
Knowledge of Windows programs (Word, Power Point, and Outlook etc.)
Bachelor degree or higher preferred
Working with industry eTMF systems
Specialized or Technical Knowledge Licenses, Certifications needed: ICH-GCP
Knowledge in clinical studies and Pharmaceutical R&D
Knowledge in Regulatory requirements for clinical trials (ICH/GCP, FDA, EU Directive)
Knowledge of document management best practices.
Already Working @TEVA?
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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
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