Principal Project Data Manager at Syneos Health Clinical Solutions

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

• On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project 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
• May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM)
• Development and adherence to standards across a program of projects
• Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (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, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
• Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
• Supports the management of resources on assigned projects/programs
• Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment
• Develops and maintains project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits
• May participate in or lead Data Management/Operations process improvement initiatives
• May supervise/line manage others
• Participates in the development of departmental technologies, SOPs, processes, and procedures
• Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training.
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business
• May represent Data Management/Data Operations in company-wide initiatives
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

Qualifications

What we’re looking for

• Progressively responsible work experience in line with the expectations of the role.
• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
• Extensive Clinical data management experience or an equivalent combination of education and experience.
• Extensive experience in Clinical Data Management practices and relational database management software systems.
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills.
• Contract Research Organization (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 navigation, 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, as well as part of a multi-disciplinary team.
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
• Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management