TMF Lead with experience in clinical trials Home Based LATAM
Syneos Health - Área metropolitana de Santiago
Sueldo líquido: No especificaPublicado el 19/ sep /2023 (hace 11 días) En syneoshealth
Description TMF Lead with experience in clinical trials Home Based LATAM (ideal opportunity for InHouse CRA interested in TMF) Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • 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 • JOB SUMMARY Provides oversight of all electronic and/or paper Trial Master File (TMF) management activities for assigned projects from award to final transfer. Drives and oversees successful completion of all TMF scoped deliverables including TMF Plan development, TMF set-up, monitoring document submissions/publishing and processing, oversight and coordination of Quality Control (QC) processes, internal and external audit representation, TMF shipments, etc. Involved in monthly project reviews evaluating operational and financial Key Performance Indicators. JOB RESPONSIBLITIES Attends Trusted Process meetings such as Kick-Off, 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. Evaluates and provides recommendations on optimal TMF set-up. Drives the TMF set-up, structure, and completeness reports. Actively involved in Collaborative Workspace including set-up and 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 audit-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. Designs and/or delivers study specific TMF training in various formats via teleconference, video conference, and/or in person. • Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF. Provides regular feedback to the Project Team on TMF health/status, including actionable metrics. As necessary,provides re-training to the Project Team. Represents the TMF during Quality Finish Meetings, provides guidance to the Project Team and TMF Operations Team on perfoming the final QC/Completeness Review, and oversees the TMF Shipment. Ensures thorough understanding of contracted scope, timeline, and budget for the TMF. Works with department management to monitor TMF team performance to the budget and documents any out-of-scope work in Change Notification Form/Change Orders as required. Presents monthly TMF status, risks, issues and associated actions for assigned projects during the Project Review Meeting (PRM). Generates and provides Completeness Reports to the Project Team Qualifications What we’re looking for • Undergraduate degree and moderate experience in a Contract Research Organization or related field. Experience with leading/co-leading studies from award into maintenance through close-out on a global scale. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. Ability to perform several tasks simultaneously to meet deadlines. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
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