Sobre

Manager, Clinical Data Management 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. 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 Ensures project launch, conduct, and closeout activities are performed according to the Customer's and the Company's contractual agreement. Ensures that 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 of a project. Ensures project documentation is filed on an ongoing basis and the TMF is maintained in an inspection ready state Manages multiple projects ranging in size and complexity from single service studies, to multiple global projects within a program, with interaction from supervisor as required  May serve as the sponsor liaison May proactively manage the scope, budget, and resource for their assigned projects under the guidance of an Associate Director/Director. Manages the financial aspects of the assigned projects, including ensuring projects maintain the correct level of gross profit, and changes in scope are applied as necessary. Ensures that customers are invoiced in a timely manner. Identify data management project issues and alert Manager (Senior Department Management) with a view to remedial action. May serve as point of escalation for individual projects. Ensure effective communication between departments and with Sponsor to ensure a high level of client satisfaction through successful execution of projects. May review Protocol, Data Management Plan, CRF and Edit Check Specifications to ensure consistency across documentation Ensures a review of relevant project Data Management study files for currency and accuracy, including development of a corrective action plan for quality issues or non-compliance. Line Management and functional support of assigned staff. Interview, onboard and train new staff as appropriate. Oversee professional development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. Mentors staff in general team leadership skills, project management skills, internal Company processes, and for project specific tasks. Manage the resources / workload of assigned team and projects, assigns tasks to team members, manage billable and non-billable time, and subsequently monitors productivity / utilization, timeliness, and quality. Maintains and evaluates project progress. May work with PDMs to prepare for and attend Project Review Meetings May participate in Sponsor or regulatory audits May represent Clinical Data Management at Business Development and Sponsor-related meetings with support from the Associate Director/Director. May perform training for data management staff to internal and external audiences as required Maintains departmental resourcing tracking tools May lead or participate in process improvement/departmental strategic initiatives to support the Business. This may include the development of departmental technologies, SOPs, processes and procedures Maintains proficiency in Data Management systems and processes through regular training Performs other work-related duties as assigned 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. https://www.syneoshealth.com 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 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. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.