Clinical Trial Associate II, TMF Operations Specialist
hace 7 días
Job Title: Clinical Trial Associate II, TMF Operations Specialist
Job Summary:
We are seeking a highly organized and detail-oriented Clinical Trial Associate II, TMF Operations Specialist to join our team at Worldwide Clinical Trials. In this role, you will be responsible for processing, maintaining, and archiving all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Responsibilities:
- Fulfill the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
- Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in both electronic and hard copy formats.
- Prepare periodic TMF Quality Control checklists for review by Project Team members.
- Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
- Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
Requirements:
- Possess data collection, indexing, and editing skills, including the ability to adhere to standardized document naming conventions.
- Possess excellent written and verbal communication skills to clearly and concisely present information.
- Display strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment.
- Handle multiple, highly detailed tasks with exceptional accuracy and demonstrate strong planning and organizational skills.
- Demonstrate proficiency in Microsoft Word and Excel and develop proficiency in the use of an electronic document repository or eTMF. General understanding of clinical research principles and processes.
- University degree preferred (Life Science desirable)
- Up to 1-2 years of relevant experience
- Knowledge of working within a highly regulated industry (desirable)
Why Worldwide Clinical Trials?
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed.
Join our team:
As a Clinical Trial Associate II, TMF Operations Specialist, you will be part of a dynamic team that is united in our cause to improve the lives of patients through new and innovative therapies.
About Worldwide Clinical Trials:
Worldwide Clinical Trials is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases is applied to develop flexible plans and solve problems quickly for our customers.
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