Precision Medicine Group
Position Summary: The Quality Review Specialist is responsible for performing periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality. The Quality Reviews are used to evaluate the completeness status of study TMFs and are critical to ensuring TMFs are maintained in an audit-ready manner. The Quality Review Specialist will be assigned responsibility for the less complex and/or smaller studies in the Precision portfolio. Essential functions of the job include but are not limited to: Performs periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality Ensures that TMF documentation related to periodic TMF Quality Reviews is generated and filed in the TMF. Informs the TMF Lead if the TMF is not updated with the information related to countries, sites, contacts and applicable TMF document requirements. Supported by Manager, monitors and escalates to the TMF Lead document processing issues and inconsistences, missing/incorrect documents filed by the Functional Leads, non-response of the Functional Leads related to periodic Quality Review requests or questions. During periodic Quality Reviews, supports updates to expected documents and opening of placeholders in TMF, where needed. Where possible, identifies potential training needs for all team members working in the TMF to encourage high quality and consistent maintenance of the TMF. Supported by Manager, identifies and escalates to TMF leadership studies at serious risk based on poor quality.
Minimum Required: Bachelor’s degree (or its international equivalent) + 2 years of related experience Other Required: Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint) Experience with eTMF systems and vendors Working knowledge of FDA & ICH/GCP regulations and guidelines
Demonstrates solid interpersonal skills Ability to identify issues and escalate appropriately and effectively Good organizational skills, time management, and ability to coordinate workload and meet established deadlines Competencies Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders Communicates both verbally and in written form in an efficient and professional manner Demonstrates values and a work ethic consistent with Precision Values and Company Principles Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com . Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.