Senior Clinical Data Lead

The point of contact for day to day activity on a study with key responsibilities for study  set-up  and close-out  tasks  as well  as overseeing  and coordinating  tasks delegated  to the study  team members  both  locally  and  in other  offices.

• Coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies.

• Reporting to the Project Manager I Sr. Project Manager, Data Management.

Responsibilities:

• Recognize, exemplify and adhere to ICON’s values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 10%) domestic I international.
• Read, ensure understanding and adhere to all assigned ICON/Client SOPs and working procedures.
• Ensure all work performed is of high quality , compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
• Complete all assigned training (including the COL Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.
• Record all billable and non-billable time in the appropriate timesheet management system (e.g. Planview™).
• Independently prepare all materials and take part in study kick off (internal and external) meeting.
• Read, ensure understand ing and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study.
• Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst.
• Independently compile the change order log and distribute internally as per ICON’s change order process.
• Demonstrate an understanding of the revenue recognition and revenue forecasting process by independently performing revenue recognition and revenue forecasting process on a monthly basis.
• Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.
• Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS).
• Lead development of the data management plan and study specific procedures.
• Ensure effective implementation of standard metric and status reporting on the study.
• Lead development of specifications for custom reporting on the study.
• Independently perform project planning tasks and develop the project plan and timelines.
• Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors.
• Adhere to ICON/Client SOPs, the Data Management Plan, Working procedures and study specific procedures in the implementation of tasks on the study.
• Adhere to the project plan and timelines in the implementation of study tasks during set-up, maintenance and close-out of the study.
• Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components.