Job Description

Description Manager, Trial Master File (TMF) Operations 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 . Participates in and directs activities related to department staff operations such as interviewing and selection, professional development, training, performance management, and employee counseling and separations. . Conducts courses of action on interviewing and selection, terminations, professional development, performance appraisals and employee counseling. . Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods. . Assigns resources and manages transitions of ongoing studies/processes/workflows. . Manages periodic and ongoing compliance to quality and performance standards of direct reports. . Ensures successful delivery of the TMF Operations Key Performance Indicators for direct reports. . Ensures staff utilization meets department goal, reviews and approves timecards/expenses by established deadline and reviews and ensures staff training compliance. . Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF. . Designs and/or delivers TMF training in various formats via teleconference, video conference, and/or in person. . Actively involved and/or leads department and business unit improvement initiatives. . Coordinates with staffing vendor to manage temporary and/or flexible workforce, as applicable. . Controls access to the Document Control Room according to applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs). Responsible for maintenance of the physical space in the Document Control work area, as applicable. . Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). Qualifications What we\'re looking for . Should Have 8 Years of Minimum work experience in ETMF Process. . Should Have 5 Years of experience in Line Management.. . Should have experience in Project Management. . Undergraduate degree. Moderate experience in a clinical and/or medical environment that includes working with regulatory records. . Experience with direct line management of staff highly preferred. . Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology. . Demonstrated leadership skills. . Strong verbal, written, and organizational skills with a team-oriented approach. . Proficiency in Electronic Document Management Systems, web-based systems, Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. . Ability to handle multiple tasks to meet deadlines in a dynamic environment. 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 . Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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