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