Job Responsibilities

• Develop and execute Real World Evidence (RWE) studies, including medical writing and study protocol development
• Collaborate with cross-functional teams to ensure scientific rigor and high-quality deliverables
• Prepare draft study reports and external publications
• Contribute to the development of materials for congress presentations and manuscripts
• Primary sponsor contact for assigned projects
• Participate in business development activities

Qualification Requirements

• Minimum of 3-5 years related industry experience
• Advanced degree (Master's) in epidemiology, economics, public health or other health-related fields
• At least 2 years' experience writing protocols, study reports, and similar documents for RWE/RWLP work
• Strong personal communication and good teamwork skills
• Regional Real World Research experience required
• Fluent in written English; regional language fluency preferred (Japanese, Chinese, Korean)

Benefits

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

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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 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
• Monitors and communicates project progress to the Sponsor and project team, including use of project status reports and tracking tools/metrics
• 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 complete 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
• Trains and mentors data management staff
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training
• Performs other work-related duties as assigned

Qualifications

• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse
• Clinical data management experience or an equivalent combination of education and experience
• Experience of 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
• 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

Job Data by YubHub.