Project Data Manager

**Description**

**Senior Project Data 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.

**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
- 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 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
- Plan, manages and requests resources for assigned projects
- Develop and maintain project plans, specifications and documentation in line with SOP requirements
- Maintains documentation on an ongoing basis and ensures that all TMF filing is 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
- 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
- Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

**Qualifications**

**What we’re looking for**
- 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.
- Clinical data management experience or an equivalent combination of education and experience.
- 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.
- 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.
- Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management

**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