Senior Project Data Manager

Discipline: Biometrics
Job type: Permanent
Salary: £55000 to £65000
Contact name: Ashley Clarke

Contact email: ashley.clarke@rbwconsulting.com
Contact phone: 01293 584 300
Job ref: 22715
Published: about 1 month ago
Expiry date: 19 January 2022

Ashley Clarke @ RBW consulting is currently recruiting for a Senior Project Data Manager basis to work remotely on a permanent basis.

The successful candidate will join an evolving biopharmaceutical leader. You will be working with industry experts across the globe working towards the same goal ‘improving patients lives around the world’.

 

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 defence meetings.

•    Maintains proficiency in Data Management systems and processes through regular training. May

     attend/represent the company at professional meetings/conferences

 

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 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. 

 

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.