Project Data Manager
hace 18 horas
Join to apply for the Project Data Manager role at Syneos Health Why 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 continuously simplify and streamline our work to make Syneos Health easier to work with, and 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, innovate as a team, and help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, driven by a passion to change lives. Discover what our 29,000 employees, across 110 countries already know: 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 continuously build the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong. Job Responsibilities Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups. Coordinate the work of the assigned Data Management/Data Operations team. Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant SOPs, guidelines, and regulations. Provides project specific training to internal and external audiences as required. Responsible for financial management of assigned projects/programs, including revenue recognition, scope changes, and participation in internal project review meetings, liaising with Finance and Contracts as needed. Monitors and communicates project progress to the Sponsor and project team using project status reports and tracking tools/metrics to enable in‑stream data collection and query management. Plan, manage and request resources for assigned projects. Develop and maintain project plans, specifications and documentation in line with SOP requirements. Maintain documentation on an ongoing basis and ensure that all TMF filing is complete and up to date. Participate in internal, sponsor, third‑party, and investigator meetings. Plan for and create necessary documentation to support internal and external audits; participate in such audits. Train and mentor data management staff. Prepare input for and participate in proposal bid defense meetings. Maintain proficiency in Data Management systems and processes through regular training. Perform other work related duties as assigned. Minimal travel may be required (up to 25%). Qualifications BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. Equivalent relevant work experience considered. Clinical data management experience or equivalent combination of education and experience. Experience with Clinical Data Management practices and relational database management software systems. Strong project management skills and knowledge of project management methodologies. Demonstrated staff leadership skills. CRO experience preferred. Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. Proficiency in MS Windows, Word, Excel, PowerPoint, and email applications. Effective oral and written communication skills. Strong presentation skills. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change, to work independently, and as part of a multidisciplinary team. Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. 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. Summary Responsible for project management of all the data management services for the assigned projects. Ensures the contracted Data Management activities for projects are carried out by the Company in accordance with the executed contract and the Sponsor’s expectations. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Information Technology Equal Employment Opportunity Statement Syneos Health is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr
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