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Clinical Records & Information Management Associate

Date: May 10, 2023

Location:

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 opportunity

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

Experience Required:

• 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.)

Experience Preferred:

• Bachelor degree or higher preferred

• Working with industry eTMF systems

• Specialized or Technical Knowledge Licenses, Certifications needed: ICH-GCP

Functional Knowledge:

• 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?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

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.

Important notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

EOE including disability/veteran