Associate Manager, Trial Master File

Industry

Pharmaceuticals

Advert ID

FOX_BBBH33591

Location

Northbrook

Job Type

Permanent

Hours

Full-Time

Salary Range

Up to USD0.00 per year

No. of Openings

1

Branch Information

Ohio/W.PA Engineering - (USA) 6000 Lombardo Center Suite 400 OH Seven Hills , OH 44131

ContactNumber

216-901-8600

Job Description

Job Responsibilities:



* Assist in the day-to-day support and management of study operations including tracking study status, milestones and performing quality check activities across components of the clinical study.

* Assist in maintaining accurate and up to date study information

* Effectively communicate with study team members and work closely with Study Manager to address challenges

* Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and/or submission of documents to the TMF and ongoing document reconciliation.

* Provides vendor management support as it relates to TMF activities

* Perform quality checks on TMF records to ensure accuracy and compliance with internal standards SOPs, GCP, and ICH Guidelines.

* Other duties as assigned



Required:



* BA/BS

* Minimum of 2 years experience clinical trials within a pharmaceutical, biotechnology, CRO and/or healthcare setting

* Good understanding of the clinical research and development process and experience handling associated documents

* Highly organized and able to produce high quality work independently or as a part of a team and be able to multi-task and work in a high volume, deadline-controlled environment.

* Must have excellent interpersonal, written, verbal, and computer skills.

* Good understanding of the TMF Reference Model industry standard for TMF content and structure and demonstrated expertise in TMF document processing and archiving procedures