Detalles de la oferta

.**Description****Trial Master File (TMF) Lead II**Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.**Why Syneos Health**- #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.- We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.**Job responsibilities**- Attends Trusted Process meetings such as Kick-Off Meetings, QuickStart Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.- May provide support to Senior TMF Leads with various study specific tasks.- Evaluates and provides recommendations on optimal TMF oversight and verifies studies have been properly created and configured within the eTMF platform.- Monitor TMF completeness by initiating Completeness Checks and generating TMF completeness reports.- Actively involved in the eTMF platform including training for the internal or external team members, as applicable.- Collaborates with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state. Develops plans to increase compliance and follows up on non-compliance, if applicable.- Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project.- Delivers project-specific TMF training in various formats via teleconference, video conference, and/or in person.- Prepares and participates in project-specific audits/inspections to ensure ongoing readiness of the TMF. May participate in qualification audits as an area of growth and development.- Provides regular feedback to the Project Team on TMF health/status, including actionable metrics


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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