Manager, Clinical Data Management

hace 4 semanas


Buenos Aires, Argentina Syneos Health, Inc. A tiempo completo

About Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. 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. 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. Job Summary The position is responsible for line managing, developing and being accountable for the Clinical Data Processing, Clinical Coders, Clinical Data Associate or Project Data Managers in their assigned team; and for meeting assigned operational targets including but not limited to quality, performance, utilization retention and training. Job Responsibilities Ensure project launch, conduct, and closeout activities are performed according to the customer’s and the company’s contractual agreements. Ensure all project‑related data management tasks are completed in accordance with internal and customer quality standards, Syneos Health SOPs, and all pertinent industry/regulatory guidelines and legal requirements from commencement to closure. File project documentation on an ongoing basis and maintain the Trial Master File (TMF) in an inspection‑ready state. Manage multiple projects ranging in size and complexity, including single service studies and multiple global projects within a program. Act as sponsor liaison when required. Proactively manage the scope, budget, and resources for assigned projects under guidance of an Associate Director/Director. Manage the financial aspects of assigned projects, ensuring correct level of gross profit and applying changes in scope as necessary. Ensure customers are invoiced in a timely manner. Identify data management project issues and alert Manager with a view to remedial action, and serve as point of escalation for individual projects. Ensure effective communication between departments and with sponsor to maintain high client satisfaction. Review Protocol, Data Management Plan, CRF, and Edit Check Specifications to ensure consistency across documentation. Review relevant project data management study files for currency and accuracy, developing corrective action plans for quality issues or non‑compliance. Lead line management and functional support of assigned staff; interview, onboard, train new staff, and oversee professional development of direct reports. Mentor staff in team leadership skills, project management skills, internal company processes, and project‑specific tasks. Manage resources/workload of assigned team and projects, assign tasks, manage billable and non‑billable time, and monitor productivity/utilization, timeliness, and quality. Maintain and evaluate project progress; work with PDMs to prepare for and attend Project Review Meetings. Participate in sponsor or regulatory audits. Represent Clinical Data Management at business development and sponsor‑related meetings with support from the Associate Director/Director. Perform training for data management staff to internal and external audiences as required. Maintain departmental resourcing tracking tools. Lead or participate in process improvement and departmental strategic initiatives to support the business, including development of departmental technologies, SOPs, processes, and procedures. Maintain proficiency in data management systems and processes through regular training. Perform other work‑related duties as assigned. Additional Information / EEO Statement 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 Job Description. 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. #J-18808-Ljbffr



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