Openings at Syneos Health Clinical Solutions

Job Responsibilities

• Review of the central LNR database to assess the availability of the local laboratories being used on a project. Communicate with the project team to obtain LNRs not available in the central LNR database.
• Transcription of the raw local lab range information provided by the site monitor into the LNR database (if not available)
• QC of the LNR data entered into the central LNR database
• Provision of the protocol-specific LNR output for each relevant site for entry into EDC
• Raise queries regarding local laboratory range data to the local laboratory staff in order to resolve issues
• Undertake QC of the local laboratory normal range data output, prior to entry into EDC
• Liaise with the Clinical Data Management team regarding the provision of the project-specific local laboratory range data
• Input data into the Clinical Laboratory Data tracking database and ensure accuracy of information
• Provision of metrics to project teams regarding the status of project local laboratory range data to ensure timely collection and validation of data
• Resolution of local lab ranges/unit conversion issues with Biostatistics and Medic as required
• May support entry of the site-specific local laboratory normal ranges into EDC
• May undertake QC of the entry of the site-specific local laboratory normal ranges into EDC by DM
• Participates in internal audits as required
• May provide clinical laboratory training to CDLS and project team members
• Serves as a clinical laboratory data Subject Matter Expert (SME)

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. B.Tech or N.Dip Biomedical Technology preferred where applicable in lieu of degree, equivalent relevant work experience
• Clinical Data Management experience with particular experience of handling local laboratory data
• Experience with local laboratory data collection methods and management of local laboratory range data in clinical trials
• Understanding of laboratory analytes, their unit of measurement and associated normal and abnormal ranges for overall safety management of patients in clinical trials
• Knowledge of medical terminology
• Contract Research Organization (CRO) experience preferred
• Good communication skills
• Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail
• Able to demonstrate critical thinking with strong attention to detail
• Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management and local laboratory data management
• Ability to deal effectively with internal customers
• Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%).

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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