Tmf Quality Specialist Ii

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Summary:
This is a senior-level role reporting directly to the Director of TransPerfect Life Sciences Solutions. The TMF Quality Specialist II (QS) will be responsible for the status of the TMF for all assigned clients. The TMF Quality Specialist II will be responsible for maintaining the quality of client Trial Master File integrity and assist in conducting internal and external audits of TMF contents.
Responsibilities:

• Plan and coordinate the management of the Trial Master File (TMF) and associated processes, including system and tool development, and business processes documentation
• Assist and conduct Internal and External TMF Audits.
• Assist as an Audit Responder in resolving audit queries.
• Assist in exporting and analyzing audit tracking reports.
• Responsible for clinical/regulatory document management and archiving
• Manage documentation control systems for compliance with FDA regulations
• Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and reviewed for quality on an ongoing basis
• Work on cross functional teams including Project Management, Business Development, Client Services, Development, and IT on the implementation and management of client projects
• Stay current on regulatory changes.
• Support the Trial Management Teams in the preparation, conduct, and follow-up of internal and/or external audits/inspections
• Communicate all systematic filing issues to manager for further training evaluation
• Prepare quality metrics, as needed, for essential documents.
• Quality assurance check for each active study site for all regulatory documents, including: IRB Renewal, IRB Protocol Approval, Informed Consent Review, Signature of Co-Investigator, IRB Membership list, Lab Normal, CAP, CLIA, 1572 Form, Agreements, PI CVs
• Assist in regulatory document review and compilation of documents for FDA submissions using GCP and ICH guidelines
• Supervise temps for on-going projects
• Perform other special projects or duties when required.

About You
As a TMF Quality Specialist II, you are a:

• Creative thinker - You are curious and unafraid to ask questions
• Hard worker - You are industrious and diligent in everything you do
• Innovator - You are willing to initiate changes and introduce new ideas

Your experience includes:

• Minimum Bachelor's Degree or equivalent.
• Minimum of 5 years of experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)
• Strong experience with TMF documents including creation, tracking, implementation, maintenance, and electronic filing and QC
• Experience in Achieving and TMF reconciliation.
• Experience in the use and development of hard copy files/electronic documentation and electronic TMF
• Strong working knowledge of ICH/GCP Guidelines
• Knowledge of clinical development phases and processes
• Superior written and spoken communication skills in English
• Proficiency in Adobe Professional and Microsoft Office (Word, Excel, Outlook)

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. the requirements listed below are representative of the knowledge, skills and ability required. Reasonable accommodations may be to enable individuals to perform the essential functions.

• Must have exemplary attention to detail and outstanding organizational skills; Ability to work aggressive timelines and to communicate effectively; Must have high work output, flexibility, creative problem-solving ability and demonstrated success in working in a fast-paced, team environment.
• Computer Skills: Must be highly competent in Microsoft Word, Microsoft Excel, Adobe Acrobat and other Microsoft Office Application including ISI Tools
• Ability to read, analyze, and interpret the documents. Must have the ability to analyze and interpret written and spoken English.
• Ability to comprehend and apply principals of mathematical concepts.
• Must be able to work within time constraints and to think and respond quickly. Must possess reasoning and problem solving skills.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee is occasionally required to sit and reach with hands and arms. The employee must occasionally lift and / or move up to 30 pounds. Must be able to work and sit at a computer for an extended period of time

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.