Senior RSG Project Manager
Senior RSG Project Manager
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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.
• Responsible for overall communication and project deliverables for assigned RSG projects. May manage contracted IRT vendors and associated services.
• Provides regular updates to project team, manager and other applicable stakeholders on status of implementation efforts and issues; resolves conflicts in information and ensures that accurate and timely information is provided to all team members throughout the duration of the project for all implementation efforts or system related issues.
• Develops timeline for all newly assigned projects; coordinates key milestones with all stakeholders (including any subsequent adjustment of milestones).
• Creates business requirements document. Works with sponsor and other responsible parties (e.g., clinical project lead, biostatistician, clinical supplies manager) on design of system and incorporating necessary feedback.
• Defines RSG business requirements within project scope and obtains appropriate approvals of the document for RSG vendor specific platform.
• Assumes overall responsibility for quality of system in production. Conducts periodic reviews of system to ensure all key components are functioning correctly.
• Responsible for ensuring RSG project tasks are completed on time and within budget.
• Provides coaching and mentoring to assigned Project Specialist and other junior team members.
• Responsible for quality of systems configuration, ensuring testing is sufficient to cover all requirements and monitoring of system in production to ensure it is functioning as required.
• Manages release of system into production and initial loading of study data in accordance with Standard Operating Procedures (SOPs) and Work Instructions (W/Is).
• Assists management team in identifying areas for process improvement; leads process improvement projects.
• Identifies and works with sponsor on any system configuration updates/modifications that are needed. Provides sponsor time and budget for the change and when required obtains the change-in-scope approval before proceeding with the work.
• Trains support team on supporting the study 24/7; assists with support issues as needed.
• Tracks ongoing system and study support issues; works with study team or support as needed to improve support response and/or reduce support issues.
• Maintains proficiency in RSG systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business. May represent the Company at professional meetings or seminars.
• Responsible for ensuring all project documentation is filed, completed and accurate, including signatures obtained where necessary.
What we’re looking for:
• BA/BS in the biological sciences or related disciplines in the natural science/health care field or equivalent combination of education and experience. Moderate clinical data management experience.
• Previous experience as Project Manager and must have had prior responsibility for numerous successful projects (delivered on-time, meeting client requirements, with high team satisfaction).
• Contract Research Organization (CRO) experience preferred. Prior IVRS/IWRS and trial supply management experience required. Previous vendor management experience preferred.
• Experience with Clinical Data Management practices and relational database management software systems.
• Good knowledge of randomization, drug supply management, clinical data, and ICH/Good Clinical Practices.
• Demonstrated leadership skills.
• Proficiency in navigating MS Windows, MS Word, Excel, PowerPoint, and email applications. Effective oral and written communication 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. Ability to work independently, as well as part of a multi-disciplinary team. Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. Strong project and vendor management skills.
• Ability to travel as necessary (up to 25%)
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.
:Europe - GBR-Home-Based
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:Yes, 25 % of the Time