Sr Project Data Manager needed at Syneos Health Clinical Solutions
Syneos Health Clinical Solutions’s job vacancy, Career and Recruitment
Job title : Sr Project Data Manager jobs in Not specified
Job Location : Not specified, Johannesburg
Deadline : September 18, 2022
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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
- Trains and mentors data management staff, acts as a subject matter expert
- 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.
- 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.
- Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management
How to Apply for this Offer
Interested and Qualified candidates should Click here to Apply online