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.
Qualifications:
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
Skills:
- 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
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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.
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Skills Required
- Bachelor's degree (or international equivalent) + 2 years related experience
- Fluency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Experience with eTMF systems and vendors
- Working knowledge of FDA & ICH/GCP regulations and guidelines
- Good organizational skills, time management, and ability to meet deadlines
- Solid interpersonal skills and ability to identify issues and escalate appropriately
What We Do
Precision is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. This maximizes our clients’ insight into patient biology, delivering more predictable trial outcomes and accelerating clinical development. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.
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