Global trials for oncology, rare diseases and other complex diseases face unique challenges. Precision partners with our clients to meet them head-on through our extensive footprint across the globe. We succeed by pairing personalized clinical services with translational medicine excellence, making us the first fully integrated clinical research organization created expressly to help advance the promises of precision medicine.
Modern biomarker-informed therapeutic and diagnostic development programs involve a complex operational and data ecosystem. Multiple data streams flow from sites, central labs, and specialty labs.
At Precision, we understand that data isn't enough. Clients need information, or data with context, to make decisions that impact patient health.
Position Summary:
The Documents Specialist II is responsible for preparing TMF plans, document QC and indexing in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate.
Essential functions of the job include but are not limited to:
• Perform document QC and indexing within eTMF for assigned studies
• Monitor document submission and timely document process, to avoid developing a backlog; escalate as needed to eTMF Management for support.
• Distribute TMF metrics. Follow-up on document in clarification and ensure these are resolved timely.
• Manage the close-out activities of assigned studies, including timeline for final document submission, wrap up of document processing, close out of all documents in close-out, requesting the eTMF export, transfer to the Client and get the Acknowledgement of Receipt.
Qualifications:
• 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline.
• Minimum 5 years of clinical trial experience. Minimum 3 years of experience with TMF and/or eTMF.
Other Required:
• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint). Ability to speak English proficiently (professional level)
Competencies:
• Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance.
• Demonstrates solid interpersonal skills. 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. © 2020 Precision Medicine Group, LLC
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