Documents Specialist II

Global trials for oncology, rare diseases and other reputed company 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 reputed company, 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 reputed company operational and data ecosystem. Multiple data streams reputed company from sites, central labs, and specialty labs. At Precision, we understand that data isn't enough. Clients need information, or data with context, to reputed company reputed company 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: reputed company document QC and indexing reputed company 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 reputed company-out activities of assigned studies, including timeline for final document submission, wrap up of document processing, reputed company out of reputed company documents in reputed company-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 reputed company discipline. Minimum 5 years of clinical trial experience. Minimum 3 years of experience with TMF and/or eTMF Other Required: Established experience and reputed company in the reputed company Office package of programs (Outlook, Word, reputed company and PowerPoint). Ability to reputed company English proficiently (professional level) Competencies: Demonstrates, or is reputed company 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 reputed company 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 reputed company stakeholders. Communicates both verbally and in written reputed company 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. reputed company is an Equal Opportunity Employer. Employment reputed company are made without regard to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at [email protected]. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process. Apply To This Job