Project Data Manager
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Romania
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Tech Stack
About the role
- 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 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
- 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
Requirements
- 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 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
- 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 multidisciplinary team
- Ability to make effective decisions and manage multiple priorities in a highly dynamic environment
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data managementproject managementrelational database managementOracle ClinicalRaveInformfinancial managementdata management systemsSOP complianceaudit preparation
Soft Skills
staff leadershipeffective communicationpresentation skillsorganizational skillsplanning skillstime managementmultitaskingflexibilitydecision makingteam collaboration
Certifications
BA/BS in biological sciencesRegistered Nurse